PMA N12159S066
- Device
- SURGICEL Powder
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S066
- Product code
- LMG
- Decision date
- 2019-11-19
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Add a duplicate Analyzer which has the same functionality and will operate within the same specifications as the existing Analyzer that is already in use for the manufacture of Surgicel Powder.
Current openFDA PMA Record#
- Device
- SURGICEL Powder
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S066
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-11-19
- Decision code
- OK30
- Date received
- 2019-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a duplicate Analyzer which has the same functionality and will operate within the same specifications as the existing Analyzer that is already in use for the manufacture of Surgicel Powder.