Gynecare Interceed Absorbable Adhesion Barrier
FDA premarket approval P880047/S026 · decided 2017-03-29
Approval details
- PMA number
- P880047
- Supplement
- S026
- Supplement type
- 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
- 2017-03-03
- Decision date
- 2017-03-29
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Addition of three shelving units to the filling and packing process for the SURGICEL Family of Absorbable Hemostats and GYNECARE INTERCEED Absorbable Adhesion Barrier products manufactured at Ethicon, Sarl in Neuchatel, Switzerland.
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