PMA N12159S053
- Device
- SURGICEL SNoW Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S053
- Product code
- LMG
- Decision date
- 2019-05-23
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Approval for modifications to the labeling to reflect current device testing for bactericidal effects.
Current openFDA PMA Record#
- Device
- SURGICEL SNoW Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S053
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-05-23
- Decision code
- APPR
- Date received
- 2019-03-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifications to the labeling to reflect current device testing for bactericidal effects.