PMA P170012

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S028
Product code: PMX
Decision date: 2026-09-03
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: for a manufacturing site located at Synergy Health Marseille, SAS (STERIS group), MIN 712 Les Arnavaux - 13323 Marseille - France, as an additional sterilization site.

Current openFDA PMA Record#

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S032
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2026-09-03
Decision code: APPR
Date received: 2026-06-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a manufacturing site located at Synergy Health Marseille, SAS (STERIS group), MIN 712 Les Arnavaux - 13323 Marseille - France, as an additional sterilization site.