SURGICEL BRAND ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S061 · decided 2019-08-02
Approval details
- PMA number
- N12159
- Supplement
- S061
- 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
- 2019-07-05
- Decision date
- 2019-08-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Addition of a fourth pass of humidified intermediate fine fibers during the roller compactor/sieving manufacturing process of SURGICEL Powder at the Ethicon, San Lorenzo, Puerto Rico facility.
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