- Device
- SURGICEL FIBRILLAR Absorbable Hemostat and SURGICEL NU-KNIT Absorbable Hemostat
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S078
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2021-03-31
- Decision code
- OK30
- Date received
- 2021-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a duplicate dehumidifier unit for SURGICEL® Absorbable Hemostats manufacturing at the Ethicon SARL, Neuchatel Switzerland site