GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S049 · decided 2022-01-20
Approval details
- PMA number
- P880047
- Supplement
- S049
- 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
- 2021-12-20
- Decision date
- 2022-01-20
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Changes to inks used on the packaging components (Tyvek wrapper, foil pouch, carton) of the GYNECARE INTERCEED Absorbable Adhesion Barrier, manufactured at the Ethicon LLC site (Puerto Rico).
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