GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
FDA premarket approval P880047/S023 · decided 2016-09-20
Approval details
- PMA number
- P880047
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- 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
- 2016-08-26
- Decision date
- 2016-09-20
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for the addition of second sensor on the band sealing equipment that seals the open side of the foil pouch of the SURGICEL Family of Absorbable Hemostats and GYNECARE INTERCEED Absorbable Adhesion Barrier products manufactured at Ethicon, Sarl.
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