Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HEALTHTRONICS OSSATRON |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | SANUWAVE, INC. 11680 GREAT OAKS WAY SUITE 350 ALPHARETTA, GA 30022 |
PMA Number | P990086 |
Supplement Number | S001 |
Date Received | 10/19/2000 |
Decision Date | 05/01/2001 |
Withdrawal Date
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02/08/2021 |
Product Code |
NBN |
Advisory Committee |
Physical Medicine |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE POST MARKET APPROVAL STUDY PROTOCOL. |
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