SURGICAL SNOW ABSORBABLE HEMOSTAT
FDA premarket approval N12159/S030 · decided 2012-04-26
Approval details
- PMA number
- N12159
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICAL SNOW ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2012-03-09
- Decision date
- 2012-04-26
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR LABELING CHANGES INCLUDING UPDATED GRAPHICS, INSTRUCTIONS FOR USE, AND LANGUAGE TRANSLATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGICEL SNOW ABSORBABLE HEMOSTAT AND IS INDICATED FOR: SURGICEL ABSORBABLE HEMOSTAT (OXIDIZED REGENERATED CELLULOSE) IS USED ADJUNCTIVELY IN SURGICAL PROCEDURES TO ASSIST IN THE CONTROL OF CAPILLARY, VENOUS, AND SMALL ARTERIAL HEMORRHAGE WHEN LIGATION OR OTHER CONVENTIONAL METHODS OF CONTROL ARC IMPRACTICAL OR INEFFECTIVE. SURG
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