Surgicel Brand Absorbable Hemostat
FDA premarket approval N12159/S043 · decided 2017-03-29
Approval details
- PMA number
- N12159
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surgicel Brand Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2017-03-03
- Decision date
- 2017-03-29
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- 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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