SURGICEL ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S039 · decided 2016-09-20
Approval details
- PMA number
- N12159
- Supplement
- S039
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2016-08-26
- Decision date
- 2016-09-20
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- 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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