PMA N12159S067
- Device
- Surgicel Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S067
- Product code
- LMG
- Decision date
- 2019-12-03
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Duplication of the existing Secondary Packaging Room to a new location inside Building #4 in the Ethicon, San Lorenzo, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- Surgicel Absorbable Hemostats
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S067
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-12-03
- Decision code
- OK30
- Date received
- 2019-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Duplication of the existing Secondary Packaging Room to a new location inside Building #4 in the Ethicon, San Lorenzo, Puerto Rico facility.