PMA N12159S125
- Device
- SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S125
- Product code
- LMG
- Decision date
- 2025-09-24
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- an update to the raw material inspection process at the San Lorenzo, PR manufacturing site
Current openFDA PMA Record#
- Device
- SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S125
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2025-09-24
- Decision code
- OK30
- Date received
- 2025-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the raw material inspection process at the San Lorenzo, PR manufacturing site