PMA P990086S002

Device: HEALTHTRONICS OSSATRON
Applicant: Sanuwave, Inc.
PMA number: P990086
Supplement: S002
Product code: NBN
Decision date: 2001-03-30
Classification: Generator, Shock-wave, For Pain Relief
Generic name: Generator, shock-wave, for pain relief
Approval order statement: APPROVAL FOR CERTAIN ERGONOMIC AND SAFETY DESIGN CHANGES AND A DEVICE PERFORMANCE CHANGE, I.E., PROVIDING THE OPTION OF USING 4 HZ FREQUENCY OF THE SHOCK WAVE DELIVERY, AS WELL AS LABELING CHANGES IN THE OPERATOR MANUAL TO PROVIDE ADEQUATE INSTRUCTIONS AND INFORMATION ABOUT THESE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEALTHTRONICS OSSATRON(R) AND IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAVE FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.

Current openFDA PMA Record#

Device: HEALTHTRONICS OSSATRON
Applicant: Sanuwave, Inc.
PMA number: P990086
Supplement: S002
Product code: NBN
Generic name: Generator, shock-wave, for pain relief
Decision date: 2001-03-30
Decision code: APPR
Date received: 2001-01-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CERTAIN ERGONOMIC AND SAFETY DESIGN CHANGES AND A DEVICE PERFORMANCE CHANGE, I.E., PROVIDING THE OPTION OF USING 4 HZ FREQUENCY OF THE SHOCK WAVE DELIVERY, AS WELL AS LABELING CHANGES IN THE OPERATOR MANUAL TO PROVIDE ADEQUATE INSTRUCTIONS AND INFORMATION ABOUT THESE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEALTHTRONICS OSSATRON(R) AND IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAVE FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.