PMA N12159S117
- Device
- SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator)
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S117
- Product code
- LMG
- Decision date
- 2024-12-05
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- relocation of sealing and packaging processes and installation of a new tray sealer and label verification station
Current openFDA PMA Record#
- Device
- SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator)
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S117
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2024-12-05
- Decision code
- OK30
- Date received
- 2024-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocation of sealing and packaging processes and installation of a new tray sealer and label verification station