GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S054 · decided 2023-02-28
Approval details
- PMA number
- P880047
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GYNECARE INTERCEED Absorbable Adhesion Barrier
- Applicant
- ETHICON, Inc.
- Date received
- 2023-01-30
- Decision date
- 2023-02-28
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Adding a duplicate cutter equipment for increasing manufacturing capacity due to the transfer of Neuchatel Surgicel fabric and Interceed device manufacturing to Ethicon, LLC, San Lorenzo in Puerto Rico.
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