PMA N12159S070
- Device
- SURGICEL SNoW Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S070
- Product code
- LMG
- Decision date
- 2020-04-13
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Qualification of a replacement SURGICEL SNoW Expander equipment at Janssen Pharmaceuticals, Inc.
Current openFDA PMA Record#
- Device
- SURGICEL SNoW Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S070
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2020-04-13
- Decision code
- OK30
- Date received
- 2020-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of a replacement SURGICEL SNoW Expander equipment at Janssen Pharmaceuticals, Inc.