GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S025 · decided 2016-10-26
Approval details
- PMA number
- P880047
- Supplement
- S025
- Supplement type
- Special (Immediate Track)
- 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
- 2016-09-26
- Decision date
- 2016-10-26
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for modification of the warning statement corresponding to use of the subject device in a contaminated surgical site.
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