PMA P900009S003

Device
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S003
Product code
LPQ
Decision date
1997-03-27
Classification
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Generic name
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Approval order statement
APPROVAL FOR THE SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000(TM).

Current openFDA PMA Record#

Device
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
Applicant
Bioventus, LLC
PMA number
P900009
Supplement
S003
Product code
LPQ
Generic name
Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Decision date
1997-03-27
Decision code
APPR
Date received
1996-01-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000(TM).