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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 | S028 |
Date Received | 12/07/2018 |
Decision Date | 01/10/2019 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for endotoxin testing and limit requirements for GYNECARE INTERCEED® Absorbable Adhesion Barrier manufactured at the San Lorenzo, Puerto Rico and Neuchatel Switzerland sites. |