PMA N12159S110

Device
SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® FIBRILLAR™, SURGICEL® SNOW™
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S110
Product code
LMG
Decision date
2024-05-16
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
update on the labeling

Current openFDA PMA Record#

Device
SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® FIBRILLAR™, SURGICEL® SNOW™
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S110
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2024-05-16
Decision code
OK30
Date received
2024-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
update on the labeling