- Device
- SURGICEL® Absorbable Hemostats (SURGICEL® SNOW™)
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S115
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2024-08-28
- Decision code
- OK30
- Date received
- 2024-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing change to Expand Controlled Manufacturing Environment (CME) area for SURGICELTM SNoW Absorbable Hemostats manufactured at Ethicon LLC San Lorenzo, Puerto Rico