PMA N12159S092
- Device
- Surgicel Nu-Knit Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S092
- Product code
- LMG
- Decision date
- 2022-05-25
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Validation of a new Reactor for the oxidation of the ORC used in the manufacturing of SURGICEL NU-KNIT.
Current openFDA PMA Record#
- Device
- Surgicel Nu-Knit Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S092
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2022-05-25
- Decision code
- OK30
- Date received
- 2022-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Validation of a new Reactor for the oxidation of the ORC used in the manufacturing of SURGICEL NU-KNIT.