SURGICEL Absorbable Hemostats
FDA premarket approval N12159/S063 · decided 2019-10-24
Approval details
- PMA number
- N12159
- Supplement
- S063
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2019-07-31
- Decision date
- 2019-10-24
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Approval for packaging changes related to the automated process change from manual to automated foiling and cartoning at the Ethicon SARL, Neuchatel Switzerland site. In addition, Ethicon will harmonize SURGICEL NU-KNIT and SURGICEL® Original packaging components.
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