SURGICEL Powder Absorbable Hemostatic Powder
FDA premarket approval N12159/S046 · decided 2018-02-23
Approval details
- PMA number
- N12159
- Supplement
- S046
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGICEL Powder Absorbable Hemostatic Powder
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2018-01-31
- Decision date
- 2018-02-23
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for strengthening two contraindication statements for SURGICEL Powder Absorbable Hemostat.
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