- Device
- SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat , SURGICEL™ Fibrillar Absorbable Hemostat,
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S087
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-10-21
- Decision code
- OK30
- Date received
- 2021-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the packaging and Bergami process manufacturing steps related to the addition of automated packaging equipment.