SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S015 · decided 1996-02-01
Approval details
- PMA number
- N12159
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 1995-09-01
- Decision date
- 1996-02-01
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR A MANUFACTURING CHANGE WHICH ADDS A STEP TO FORM A FIBRILLAR STRUCTURE FOR THE DEVICE. AS MODIFIED THE DEVICE WILL MARKETED UNDER THE TRADE NAME SURGICEL
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