Cognis..... :(

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Anonymous said:
Are there any means to obtain quick FDA approvals?
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If you meet the requirements, a 510(k) submission is probably the faster route. CRM devices (leads and PGs) are PMA or PMA supplements though.

The quickest way is to have a bullet proof submission and a dullard for a reviewer. Sometimes the reviewers ask bogus questions, because their clock is running out on the statutory limit for the review period and they just need to stop the clock. Ideally, the user fees (http://www.fda.gov/MedicalDevices/D...ubmissions/PremarketApprovalPMA/ucm048161.htm) would increase and the FDA would hire more staff to decrease the reviewer burden.

Each new disaster makes the submission process more time consuming. Fidelis will have the FDA asking a lot of questions about fatigue and Riata will have them asking questions about abrasion (or lead body disintegration). The industry could also get faster approvals if there weren't major failures every couple of years.
 






Anonymous said:
If you meet the requirements, a 510(k) submission is probably the faster route. CRM devices (leads and PGs) are PMA or PMA supplements though.

The quickest way is to have a bullet proof submission and a dullard for a reviewer. Sometimes the reviewers ask bogus questions, because their clock is running out on the statutory limit for the review period and they just need to stop the clock. Ideally, the user fees (http://www.fda.gov/MedicalDevices/D...ubmissions/PremarketApprovalPMA/ucm048161.htm) would increase and the FDA would hire more staff to decrease the reviewer burden.

Each new disaster makes the submission process more time consuming. Fidelis will have the FDA asking a lot of questions about fatigue and Riata will have them asking questions about abrasion (or lead body disintegration). The industry could also get faster approvals if there weren't major failures every couple of years.
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So it's BSX/GDT who fucked it up in 2005 then...........
 






Anonymous said:
Fidelis will have the FDA asking a lot of questions about fatigue and Riata will have them asking questions about abrasion (or lead body disintegration). The industry could also get faster approvals if there weren't major failures every couple of years.
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You forgot about BSX and the following will be FDA questions:

1. Provide the properties of adhessive used in Cognis/Teligen header attachments.

2. Qualification testing data for Cognis set screws, lead ports, and acceptance testing of torque wrenches.

3. Reliability testing data for Biotronik leads.

4. Firmware validation testing data for Cognis and Teligen cans.
 






Anonymous said:
You forgot about BSX and the following will be FDA questions:

1. Provide the properties of adhessive used in Cognis/Teligen header attachments.

2. Qualification testing data for Cognis set screws, lead ports, and acceptance testing of torque wrenches.

3. Reliability testing data for Biotronik leads.

4. Firmware validation testing data for Cognis and Teligen cans.
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evidently they did not ask those questions. every submission after that will probably have those questions asked though...
 






Anonymous said:
evidently they did not ask those questions. every submission after that will probably have those questions asked though...
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Also there is a possibility that FDA would like to be present while qualification testing process so that BSX cannot cook the outcome. The FDA will also like to be present during supplier qualification, all DVT and process validation process.
 


















who cares??? the prices are so cheap and getting worse, no company is going to invest for large returns in CRM now. Its messed up and not coming back folks. Dying industry and will be now considered a comodity. Thats not a good thing for anything new or revolutionary because medicare wont pay for it. It a larger problem than what is being discussed here.
 






Anonymous said:
who cares??? the prices are so cheap and getting worse, no company is going to invest for large returns in CRM now. Its messed up and not coming back folks. Dying industry and will be now considered a comodity. Thats not a good thing for anything new or revolutionary because medicare wont pay for it. It a larger problem than what is being discussed here.
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True. I just read on the st j site that they are going to part time reps. See the per diem thread.
 




































Anonymous said:
Some reps are talking about huge recall of various cans, but no one is ready to provide any details.

It is quite possible that due to long term hiding facts, it is time the truth will be revealed soon.
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One can see that in the month of October 2011 alone there are 214 MDRs on FDA MAUDE, most of these are serious incidents. How long BSX is going to hide facts?
 






























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