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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEALTHTRONICS OSSATRON
Classification Namegenerator, shock-wave, for pain relief
Generic Nameorthopedic extracorporeal shock wave system
ApplicantHEALTH TRONICS SURGICAL SERVICES, INC.
PMA NumberP990086
Supplement NumberS002
Date Received01/12/2001
Decision Date03/30/2001
Product Code
NBN[ Registered Establishments with NBN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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.
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