Surgicel Absorbable Hemostat
FDA premarket approval N12159/S044 · decided 2017-07-06
Approval details
- PMA number
- N12159
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surgicel Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2017-06-12
- Decision date
- 2017-07-06
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Adding an automated label scanning system to verify the batch information and packaging components for product codes 435050 and 194350 at Ethicon SARL, Neuchâtel Switzerland.
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