PMA N12159S096

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S096
Product code: LMG
Decision date: 2022-12-20
Generic name: Agent, absorbable hemostatic, non-collagen based
Approval order statement: Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.

Current openFDA PMA Record#

Device: SURGICEL® Absorbable Hemostats
Applicant: ETHICON, Inc.
PMA number: N12159
Supplement: S096
Product code: LMG
Generic name: Agent, absorbable hemostatic, non-collagen based
Decision date: 2022-12-20
Decision code: OK30
Date received: 2022-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.