SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT Absorbable Hemostat, SURGICEL® SNOW Absorbable Hemostat
FDA premarket approval N12159/S104 · decided 2023-07-11
Approval details
- PMA number
- N12159
- Supplement
- S104
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT Absorbable Hemostat, SURGICEL® SNOW Absorbable Hemostat
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2023-06-15
- Decision date
- 2023-07-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Increase in the number of isopropyl alcohol (IPA) washes to remove water from the oxidized regenerated cellulose (ORC) fabric rolls prior to the drying step.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.