GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S056 · decided 2023-11-01
Approval details
- PMA number
- P880047
- Supplement
- S056
- 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
- 2023-09-29
- Decision date
- 2023-11-01
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- replacement of manual visual inspection with an automatic seal inspection machine in the Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility
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