PMA P240035S003

Device: ETHIZIA™ Hemostatic Patch
Applicant: ETHICON, Inc.
PMA number: P240035
Supplement: S003
Product code: SGV
Decision date: 2026-01-28
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen with polymeric additives
Approval order statement: the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240035

Current openFDA PMA Record#

Device: ETHIZIA™ Hemostatic Patch
Applicant: ETHICON, Inc.
PMA number: P240035
Supplement: S003
Product code: SGV
Generic name: Agent, absorbable hemostatic, collagen with polymeric additives
Decision date: 2026-01-28
Decision code: APPR
Date received: 2025-12-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240035