SURGICEL Absorbable Hemostats
FDA premarket approval N12159/S059 · decided 2019-07-23
Approval details
- PMA number
- N12159
- Supplement
- S059
- Supplement type
- 30-Day Notice
- 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
- 2019-06-24
- Decision date
- 2019-07-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes.
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