GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S030 · decided 2019-05-13
Approval details
- PMA number
- P880047
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GYNECARE INTERCEED Absorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2019-02-12
- Decision date
- 2019-05-13
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for packaging changes related to the automated process change from manual to automated foiling and cartoning at the Ethicon SARL, Neuchatel Switzerland site for GYNECARE INTERCEED Absorbable Adhesion Barrier.
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