SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S013 · decided 1996-01-16
Approval details
- PMA number
- N12159
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1993-09-15
- Decision date
- 1996-01-16
- Days to decision
- 853 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL 1)PROCESS CHANGE THAT DELETES THE USE OF THE IN-PROCESS SOLVENT FREON AND REPLACES IT WITH PERFLUOROHEXANE 2) CHANGE OF IN-PROCESS MANUFACTURING FACILITY TO NORAMCO, INC., 1440 OLYMPIC DR., P.O. BOX 800001, ATHENS, GA 30608-8001 3)CHANGE OF QUALITY ASSURANCE SITE TO, JOHNSON AND JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100 4)ADDITION OF ALTERNATE STERILIZATION SITE, JOHNSON & JOHNSON MEDICAL, INC., U.S. HIGHWAY 75S AND 1417W, SHERMAN, TX 75091-9100
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