Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GYNECARE INTERCEED™ Absorbable Adhesion Barrier |
Generic Name | Barrier, absorbable, adhesion |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | P880047 |
Supplement Number | S045 |
Date Received | 09/29/2021 |
Decision Date | 10/29/2021 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes to the sampling frequency of Bacterial Endotoxin Test (BET) lot release testing of the GYNECARE INTERCEED Absorbable Adhesion Barrier device, manufactured at ETHICON SARL, from 100% batch release testing to audit testing on a monthly basis. |
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