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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
Generic Namegenerator, shock-wave, for pain relief
Applicant
STORZ MEDICAL AG
lohstampfestrasse 8
tagerwilen CH-82-8274
PMA NumberP080028
Date Received11/26/2008
Decision Date01/08/2016
Product Code NBN 
Docket Number 16M-0122
Notice Date 01/11/2016
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY. THIS DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE TREATMENT OF HEEL PAIN DUE TO CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS OF AGE GREATER THAN 18 YEARS WITH A HISTORY OF FAILED ALTERNATIVE CONSERVATIVE THERAPIES FOR AT LEAST SIX MONTHS. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT THE ORIGIN ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 
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