GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S022 · decided 2016-10-24
Approval details
- PMA number
- P880047
- Supplement
- S022
- Supplement type
- 135 Review Track For 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
- 2016-05-19
- Decision date
- 2016-10-24
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for consolidation of the knitting processes into a single building for the sub-tier supplier, Secant Medical for the GYNECARE INTERCEED® Absorbable Adhesion Barrier.
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