Gynecare Interceed Absorbable Adhesion Barrier
FDA premarket approval P880047/S063 · decided 2025-01-30
Approval details
- PMA number
- P880047
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Gynecare Interceed Absorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2024-12-31
- Decision date
- 2025-01-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- expansion of the downstream controlled manufacturing environment (CME) area at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing facility
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