SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)
FDA premarket approval N12159/S023 · decided 2008-11-26
Approval details
- PMA number
- N12159
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2008-04-04
- Decision date
- 2008-11-26
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT: 1) ETHICON SARL, NEUCHATEL, SWITZERLAND; 2) ETHICON SARL, MARIN SWITZERLAND (WAREHOUSE); AND 3) STUDER AF/WERK HARD, DANIKEN, SWITZERLAND (CONTRACT STERILIZER).
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