FDA.reportPublic FDA data

PMA N12159S076

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S076
Product code
LMG
Decision date
2020-11-12
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Addition of SURGICEL Original and NU-KNIT Absorbable Hemostats Extra Small (XS) and NU-KNIT Medium (M) sized foil pouches to the upgraded Final Seal Inspection System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.

Current openFDA PMA Record#

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S076
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-11-12
Decision code
OK30
Date received
2020-10-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of SURGICEL Original and NU-KNIT Absorbable Hemostats Extra Small (XS) and NU-KNIT Medium (M) sized foil pouches to the upgraded Final Seal Inspection System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.