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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namegenerator, shock-wave, for pain relief
Generic Namegenerator, shock-wave, for pain relief
11680 great oaks way
suite 350
alpharetta, GA 30022
PMA NumberP990086
Date Received12/30/1999
Decision Date10/12/2000
Product Code
NBN[ Registered Establishments with NBN ]
Docket Number 01M-0271
Notice Date 06/18/2001
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device is indicated for use for performing extracorporeal shock wave treatment in patients with chronic proximal plantar fasciitis that has failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for six months or more.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004