PMA N12159S059
- Device
- SURGICEL Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S059
- Product code
- LMG
- Decision date
- 2019-07-23
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes.
Current openFDA PMA Record#
- Device
- SURGICEL Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S059
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-07-23
- Decision code
- OK30
- Date received
- 2019-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes.