SURGICEL FAMILY OF ABSORBABLE HEMOSTATS
FDA premarket approval N12159/S041 · decided 2016-10-24
Approval details
- PMA number
- N12159
- Supplement
- S041
- 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
- 2016-10-24
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Addition of filling/ folding stations. The production capacity of the room increased to allowing 36 operators to perform the existing process at the same time. The above change is located at room 217 in Puits Godet20, Neochatel CH-2000, Switzerland.
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