FDA.reportPublic FDA data

PMA N12159S083

Device
SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S083
Product code
LMG
Decision date
2021-09-10
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the Ethicon, LLC, San Lorenzo, Puerto Rico facility.

Current openFDA PMA Record#

Device
SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S083
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2021-09-10
Decision code
OK30
Date received
2021-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the Ethicon, LLC, San Lorenzo, Puerto Rico facility.