GYNECARE INTERCEED Absorbable Adhesion Barrier
FDA premarket approval P880047/S047 · decided 2022-03-07
Approval details
- PMA number
- P880047
- Supplement
- S047
- 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
- 2021-11-30
- Decision date
- 2022-03-07
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for the addition of three additional size varieties (3 inches x 2 inches, 3 inches x 5 inches, and 3 inches x 6 inches) to the GYNECARE INTERCEED Absorbable Adhesion Barrier device line.
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