PMA P170012S029

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
Product code: PMX
Decision date: 2024-11-06
Generic name: Absorbable collagen hemostatic agent with thrombin
Approval order statement: Approval for removal of the neurosurgical exception from the currently approved indications for use and modification of the name of the approved HEMOBLAST™ Bellows Laparoscopic Applicator to the HEMOBLAST™ Bellows 35 cm Nozzle Extension.

Current openFDA PMA Record#

Device: HEMOBLAST™ Bellows
Applicant: Dilon Technologies, Inc.
PMA number: P170012
Supplement: S029
Product code: PMX
Generic name: Absorbable collagen hemostatic agent with thrombin
Decision date: 2024-11-06
Decision code: APPR
Date received: 2024-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for removal of the neurosurgical exception from the currently approved indications for use and modification of the name of the approved HEMOBLAST™ Bellows Laparoscopic Applicator to the HEMOBLAST™ Bellows 35 cm Nozzle Extension.