SURGICEL Original Absorbable Hemostat
FDA premarket approval N12159/S064 · decided 2019-10-08
Approval details
- PMA number
- N12159
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL Original Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2019-09-09
- Decision date
- 2019-10-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Mechanical and system upgrades on the automated Foiling Line G11719 for the inspection of hermetically sealed SURGICEL original foil pouches to add cameras to image the bottom of the foil pouch and a modification of the vision conveyor to accommodate the added cameras.
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