SURGICEL Absorbable Hemostats
FDA premarket approval N12159/S051 · decided 2018-12-07
Approval details
- PMA number
- N12159
- Supplement
- S051
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2018-11-08
- Decision date
- 2018-12-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for a change to implement endotoxin testing and limit requirements for the Surgicel Original, Surgicel SNoW, Surgicel Fibrillar, and Surgicel Nu-Knit devices.
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