PMA N12159S075

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S075
Product code
LMG
Decision date
2020-11-03
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Changes related to the SURGICEL and INTERCEED cartoning line at the Ethicon Sarl, Neuchatel manufacturing site.

Current openFDA PMA Record#

Device
SURGICEL Absorbable Hemostats
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S075
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-11-03
Decision code
OK30
Date received
2020-10-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes related to the SURGICEL and INTERCEED cartoning line at the Ethicon Sarl, Neuchatel manufacturing site.