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PMA N12159S081

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S081
Product code
LMG
Decision date
2021-08-16
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Change to the sampling plan used in the Finished Goods testing and incoming inspection of components of SURGICEL Absorbable Hemostats at Ethicons Puerto Rico site.

Current openFDA PMA Record#

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S081
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2021-08-16
Decision code
OK30
Date received
2021-07-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the sampling plan used in the Finished Goods testing and incoming inspection of components of SURGICEL Absorbable Hemostats at Ethicons Puerto Rico site.