SURGICEL FAMILY OF HEMOSTATS
FDA premarket approval N12159/S033 · decided 2014-09-24
Approval details
- PMA number
- N12159
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL FAMILY OF HEMOSTATS
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2014-07-07
- Decision date
- 2014-09-24
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL TO INCLUDE X-RAY IRRADIATION AS AN ALTERNATIVE STERILIZATIONPROCESS.
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