PMA N12159S091

Device: SURGICEL SNoW™ Absorbable Hemostat
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S091
Product code: LMG
Decision date: 2022-01-19
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Duplication of the existing dehumidification process for SURGICEL SNoW products in Dehumidification Chamber #3 at Ethicon LLC San Lorenzo, Puerto Rico facility.

Current openFDA PMA Record#

Device: SURGICEL SNoW™ Absorbable Hemostat
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S091
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Duplication of the existing dehumidification process for SURGICEL SNoW products in Dehumidification Chamber #3 at Ethicon LLC San Lorenzo, Puerto Rico facility.