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.