PMA N12159S064
- Device
- SURGICEL Original Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S064
- Product code
- LMG
- Decision date
- 2019-10-08
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Mechanical and system upgrades on the automated Foiling Line G11719 for the inspection of hermetically sealed SURGICEL original foil pouches to add cameras to image the bottom of the foil pouch and a modification of the vision conveyor to accommodate the added cameras.
Current openFDA PMA Record#
- Device
- SURGICEL Original Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S064
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-10-08
- Decision code
- OK30
- Date received
- 2019-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Mechanical and system upgrades on the automated Foiling Line G11719 for the inspection of hermetically sealed SURGICEL original foil pouches to add cameras to image the bottom of the foil pouch and a modification of the vision conveyor to accommodate the added cameras.