PMA N12159S061
- Device
- SURGICEL BRAND ABSORBABLE HEMOSTAT
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S061
- Product code
- LMG
- Decision date
- 2019-08-02
- Classification
- Agent, Absorbable Hemostatic, Non-collagen Based
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Approval order statement
- Addition of a fourth pass of humidified intermediate fine fibers during the roller compactor/sieving manufacturing process of SURGICEL Powder at the Ethicon, San Lorenzo, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- SURGICEL BRAND ABSORBABLE HEMOSTAT
- Applicant
- ETHICON, Inc.
- PMA number
- N12159
- Supplement
- S061
- Product code
- LMG
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Decision date
- 2019-08-02
- Decision code
- OK30
- Date received
- 2019-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a fourth pass of humidified intermediate fine fibers during the roller compactor/sieving manufacturing process of SURGICEL Powder at the Ethicon, San Lorenzo, Puerto Rico facility.