PMA N12159S074

Device
SURGICEL Absorbable Hemostat
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S074
Product code
LMG
Decision date
2020-08-14
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Change to the Roller Compaction machines Programmable Logic Controller software.

Current openFDA PMA Record#

Device
SURGICEL Absorbable Hemostat
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S074
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-08-14
Decision code
OK30
Date received
2020-07-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the Roller Compaction machines Programmable Logic Controller software.