PMA P240035S004

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S004
Product code
SGV
Decision date
2026-08-27
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Approval order statement
approval for a manufacturing site located at Herotran E-Beam Service GmbH, sterilizer, Guardianstr. 6-10, Bitterfeld-Wolfen, DE

Current openFDA PMA Record#

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S004
Product code
SGV
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Decision date
2026-08-27
Decision code
APPR
Date received
2026-01-30
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for a manufacturing site located at Herotran E-Beam Service GmbH, sterilizer, Guardianstr. 6-10, Bitterfeld-Wolfen, DE