PMA N12159S094
- Device
- SURGICELTM Family of Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S094
- Product code
- LMG
- Decision date
- 2022-07-08
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Establish a new slit and cutting room in the Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility.
Current openFDA PMA Record#
- Device
- SURGICELTM Family of Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S094
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2022-07-08
- Decision code
- OK30
- Date received
- 2022-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Establish a new slit and cutting room in the Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility.