|
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 | S043 |
Date Received | 09/03/2021 |
Decision Date | 01/21/2022 |
Product Code |
MCN |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the introduction of a new replacement metal detector for detecting metal particles in the cut Oxidized Regenerated Cellulose (ORC) at your San Lorenzo, Puerto Rico manufacturing site. |