Pico FDA

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Anonymous

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Been gone long time since last June, when the top management liars told us Renasy would be back in months, that this was a small "snafu", which obviously was not true. I read with a chuckle on these posts, most recently the Pico stuff. I always wondered. When Pico first came out, the pico engine was separated from the dressing kit. The dressing kit was sterile and when they hooked the tubing of the dressing kit to the non sterile Pico, they would do so right on the line of sterility, Same process for wound vac. SN changed Pico later on, in that the entire Pico and dressing was all in a sterile kit. Additionally, the hub on the Pico engine prior to luer locking to the dressing tubing, was a 4 inch tube extending from the Pico which was not secured well. SN then build the hub right onto the Pico, and the tubing from the dressing would luer lock right into the hub. All this being said, I did a search on the FDA sight. I see the 510k approval for the original Pico back in 2011 or so. However, I never saw any 510k approval for the changes they made to Pico (all sterile pack, hub moved onto the pico engine, etc) a few years later. It is my understanding that any changes to a device, whether it be slight, new labeling, sterility factors, etc, have to have 501k approval. You do not thing that after losing 90million to Renasys, they did not bother to have the changes to Pico 510k approved? If so, this would be a new low of arrogance, incompetence, and flat our debauchery.
 






Anonymous said:
Been gone long time since last June, when the top management liars told us Renasy would be back in months, that this was a small "snafu", which obviously was not true. I read with a chuckle on these posts, most recently the Pico stuff. I always wondered. When Pico first came out, the pico engine was separated from the dressing kit. The dressing kit was sterile and when they hooked the tubing of the dressing kit to the non sterile Pico, they would do so right on the line of sterility, Same process for wound vac. SN changed Pico later on, in that the entire Pico and dressing was all in a sterile kit. Additionally, the hub on the Pico engine prior to luer locking to the dressing tubing, was a 4 inch tube extending from the Pico which was not secured well. SN then build the hub right onto the Pico, and the tubing from the dressing would luer lock right into the hub. All this being said, I did a search on the FDA sight. I see the 510k approval for the original Pico back in 2011 or so. However, I never saw any 510k approval for the changes they made to Pico (all sterile pack, hub moved onto the pico engine, etc) a few years later. It is my understanding that any changes to a device, whether it be slight, new labeling, sterility factors, etc, have to have 501k approval. You do not thing that after losing 90million to Renasys, they did not bother to have the changes to Pico 510k approved? If so, this would be a new low of arrogance, incompetence, and flat our debauchery.
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nothing would surprise me anymore with this train wreck
 












Anonymous said:
People in Andover saying FDA is gonna look into the Pico changes. how many times we gonna do this?
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This is just beyond belief. How can a Company this big not only allow the Renasys to go due to lies, and omissions, but what if, just what if, the same holds true on Pico. Looked into FDA 510k for the changes to Pico and I cannot find anything other than the original 510k given, when Pico was first launched. Unless for some reason, they do not publish this date for around 2012/2013, when the "changes to Pico were made, then what gives? At least Oasis is doing well.
 






Anonymous said:
This is just beyond belief. How can a Company this big not only allow the Renasys to go due to lies, and omissions, but what if, just what if, the same holds true on Pico. Looked into FDA 510k for the changes to Pico and I cannot find anything other than the original 510k given, when Pico was first launched. Unless for some reason, they do not publish this date for around 2012/2013, when the "changes to Pico were made, then what gives? At least Oasis is doing well.
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If changes are "small" you can do a Letter to File yourself without re-filing the 510k.

Don't know if these changes are "small" enough.
 
























Anonymous said:
Prove it. No changes made.
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The changes were made troll, or currently employed jackass. Perhaps your sorry ass was not employed at the time. I am just so happy to be away from this miserable organization, and having found a great opportunity with an outfit that has some integrity, a word which SN simply does not understand.
 






Anonymous said:
There they go again trying to belittle the incredible success now taking place with pico. Move on with your life it's been months. Focus on your miserable career
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You are either a pozer, or completely full of BS. "Incredible Success" for Pico is like saying the Knicks are having a great season. For many who moved on, they are not miserable like the punk that you are, they are elated to have left this organization run by misfits and sociopathic liars. Whoever started the post was making an observation. They already pissed off the FDA once, perhaps, they have done it again. The only belittling I will hand out is the vacancy between your ears.
 






Anonymous said:
There they go again trying to belittle the incredible success now taking place with pico. Move on with your life it's been months. Focus on your miserable career
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Incredible success. Tell that to St Joe's OP WC Center in Chicago. They were raving at how much Pico they used, until Jan 1 reimbursement changes came about. Let's see, the Pico costs approx. 225 per box, reimbursement is approx. $144. Yes, I know this place, which they did copious webcasts on, and was the only place of significance they could talk about; is going to lost $81 per placement. Yes, in Canada which is socialized, they can order whatever they want. In the US, the only place Pico is going on are high risk incisions. These are very finite, in terms of volume. Yes, there are always big time users here and there, but over the long haul, Pico will never render "incredible success" as it is a niche product.
 






If you are so happy why can't you move on. Focus on your new widget. It's obvious the resentment that you still foster. Glad you are gone at least we only have to read your constant bitching if we want to.
 






Anonymous said:
If you are so happy why can't you move on. Focus on your new widget. It's obvious the resentment that you still foster. Glad you are gone at least we only have to read your constant bitching if we want to.
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I foster no resentment, just joy to be gone. However, posting the truth seems to bother you as you have yet to respond with a reasonable mature answer. You seem destined to circle the drain in this trainwreck. The truth is the truth, and though it may be difficult for you to comprehend this, this is not bitching, but just laying it out. You may need to get a prescription for kool aid induced anger management.
 




































Love how SN keeps people who have not received a subpeona from DOJ/FDA in the dark defending bad decisions. Once you realize you have been thrown under the bus you will understand.
 






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