FDA.reportPublic FDA data

PMA N12159S077

Device
SURGICEL Absorbable Hemostat
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S077
Product code
LMG
Decision date
2020-12-22
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Implementation of X-Ray Sterilization as an alternative to Gamma Sterilization for SURGICEL Absorbable Hemostats at the Ethicon Sarl, Neuchatel Manufacturing site.

Current openFDA PMA Record#

Device
SURGICEL Absorbable Hemostat
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S077
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-12-22
Decision code
OK30
Date received
2020-11-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of X-Ray Sterilization as an alternative to Gamma Sterilization for SURGICEL Absorbable Hemostats at the Ethicon Sarl, Neuchatel Manufacturing site.