PMA P170012S030

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S030
Product code: PMX
Decision date: 2025-03-31
Classification: General, Plastic Surgery
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: a change in the raw material used to produce inner and outer pouches used in the nozzle extension packaging, and a change to the supplier for the nozzle extension pouches sealing

Current openFDA PMA Record#

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S030
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2025-03-31
Decision code: OK30
Date received: 2025-03-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the raw material used to produce inner and outer pouches used in the nozzle extension packaging, and a change to the supplier for the nozzle extension pouches sealing