PMA N12159
- Device
- SURGICEL® Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S096
- Product code
- LMG
- Decision date
- 2026-01-15
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- a change in foil roll-stock raw material manufactured at AMCOR Flexibles and a supplier address change for AMCOR Flexibles
Current openFDA PMA Record#
- Device
- SURGICEL® Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S128
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2026-01-15
- Decision code
- OK30
- Date received
- 2025-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in foil roll-stock raw material manufactured at AMCOR Flexibles and a supplier address change for AMCOR Flexibles