SURGICEL FAMILY OF ABSORBABLE HEMOSTATS
FDA premarket approval N12159/S042 · decided 2016-10-25
Approval details
- PMA number
- N12159
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL FAMILY OF ABSORBABLE HEMOSTATS
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2016-09-27
- Decision date
- 2016-10-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for the Bergami G10102 transferred to room 221 and re-qualified to overwrap US SURGICEL product codes, which includes medium and large carton boxes. The above change is located at room 221 in Puits Godet20, Neochatel CH-2000, Switzerland
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