GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S052 · decided 2022-12-20
Approval details
- PMA number
- P880047
- Supplement
- S052
- 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
- 2022-11-21
- Decision date
- 2022-12-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.
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