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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 | S032 |
Date Received | 06/24/2019 |
Decision Date | 07/23/2019 |
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 Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes. |