GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S055 · decided 2023-11-14
Approval details
- PMA number
- P880047
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GYNECARE INTERCEED Absorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- ETHICON, Inc.
- Date received
- 2023-08-22
- Decision date
- 2023-11-14
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.
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