GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S041 · decided 2021-08-31
Approval details
- PMA number
- P880047
- Supplement
- S041
- 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
- 2021-08-02
- Decision date
- 2021-08-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Expansion of the controlled manufacturing environment (CME) in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.
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