PMA N12159S127

Device
SURGICEL® Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S127
Product code
LMG
Decision date
2025-12-12
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
additional equipment to improve efficiency in production

Current openFDA PMA Record#

Device
SURGICEL® Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S127
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2025-12-12
Decision code
OK30
Date received
2025-11-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
additional equipment to improve efficiency in production