PMA N12159S079
- Device
- SURGICEL Family of Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S079
- Product code
- LMG
- Decision date
- 2021-04-01
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Change of ink used for the inline printing on SURGICEL® product cartons at Ethicon SARL in Neuchatel, Switzerland.
Current openFDA PMA Record#
- Device
- SURGICEL Family of Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S079
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of ink used for the inline printing on SURGICEL® product cartons at Ethicon SARL in Neuchatel, Switzerland.