PMA N12159S116
- Device
- SURGICEL Powder Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S116
- Product code
- LMG
- Decision date
- 2024-12-13
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- revising the release specification and the extending of the shelf-life
Current openFDA PMA Record#
- Device
- SURGICEL Powder Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S116
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2024-12-13
- Decision code
- APPR
- Date received
- 2024-09-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- revising the release specification and the extending of the shelf-life