PMA P240035S006

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S006
Product code
SGV
Decision date
2026-02-24
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Approval order statement
change of certain cleanroom airborne particulate matter classifications from class 7 to class 8

Current openFDA PMA Record#

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S006
Product code
SGV
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Decision date
2026-02-24
Decision code
OK30
Date received
2026-01-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
change of certain cleanroom airborne particulate matter classifications from class 7 to class 8