- Device
- SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S082
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the controlled manufacturing environment (CME) in the Ethicon, LLC, San Lorenzo, Puerto Rico facility.