PMA P170012S024

Device
HEMOBLAST Bellows
Applicant
Dilon Technologies, Inc.
PMA number
P170012
Supplement
S024
Product code
PMX
Decision date
2021-01-13
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Modification to the facility floorplan at the HEMOBLAST Bellows manufacturing facility.

Current openFDA PMA Record#

Device
HEMOBLAST Bellows
Applicant
Dilon Technologies, Inc.
PMA number
P170012
Supplement
S024
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2021-01-13
Decision code
OK30
Date received
2020-12-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the facility floorplan at the HEMOBLAST Bellows manufacturing facility.