PMA P170012S026

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
Product code: PMX
Decision date: 2021-10-28
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: Approval for modifications to the production equipment used in the Basic Fibrous Collagen (FB05) manufacturing process for the manufacture of HEMOBLAST™ Bellows Hemostatic Powder.

Current openFDA PMA Record#

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S026
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2021-10-28
Decision code: APPR
Date received: 2021-03-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the production equipment used in the Basic Fibrous Collagen (FB05) manufacturing process for the manufacture of HEMOBLAST™ Bellows Hemostatic Powder.