SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S017 · decided 1999-05-05
Approval details
- PMA number
- N12159
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1998-08-28
- Decision date
- 1999-05-05
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for an additional location for the final product release located at Ethicon, Inc., U.S. Route 22, Somerville, NJ 08876 and duplication of final packaging process at Ethicon, Inc., Road 183 KM 8.3, Industrial Area Hato, San Lorenzo, Puerto Rico 00754.
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