PMA N12159S080
- Device
- SURGICEL NU-KNIT Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S080
- Product code
- LMG
- Decision date
- 2021-07-30
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Change to the cutter machine used in the manufacturing of SURGICEL Nu-Knit Absorbable Hemostats at the Ethicon LLC Puerto Rico site.
Current openFDA PMA Record#
- Device
- SURGICEL NU-KNIT Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S080
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-07-30
- Decision code
- OK30
- Date received
- 2021-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the cutter machine used in the manufacturing of SURGICEL Nu-Knit Absorbable Hemostats at the Ethicon LLC Puerto Rico site.