GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S035 · decided 2020-05-20
Approval details
- PMA number
- P880047
- Supplement
- S035
- 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
- 2020-04-20
- Decision date
- 2020-05-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Supplier change to increase the quantity of black pigment in the HAPA UV cured ink used to print artwork graphics on the exterior of the GYNECARE INTERCEED Adhesion Barrier foil pouches manufactured on the automated Foiling Line (G11719) at the EthiconSARL, Neuchâtel, Switzerland site.
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