- Device
- SURGICEL® Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S107
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2023-11-01
- Decision code
- OK30
- Date received
- 2023-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- replacement of manual visual inspection with an automatic seal inspection machine in the Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility