PMA P170012S028

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S028
Product code: PMX
Decision date: 2022-04-22
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: Approval for the modification of the blending method for the three constituent components that compose the finished HEMOBLAST Bellows Hemostatic Powder in the manufacturing process.

Current openFDA PMA Record#

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S028
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2022-04-22
Decision code: APPR
Date received: 2021-11-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the modification of the blending method for the three constituent components that compose the finished HEMOBLAST Bellows Hemostatic Powder in the manufacturing process.