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.
Approval for insertion of a table of adverse events and a brief paragraph following the post-approval study of esw treatment of plantar fasciitis constituting the labeling changes in the operating manual.
Device | HEALTHTRONICS OSSATRON |
Classification Name | Generator, Shock-wave, For Pain Relief |
Generic Name | Generator, Shock-wave, For Pain Relief |
Applicant | SANUWAVE, INC. |
Date Received | 2004-02-09 |
Decision Date | 2004-08-06 |
PMA | P990086 |
Supplement | S004 |
Product Code | NBN |
Advisory Committee | Physical Medicine |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | SANUWAVE, INC. 11680 Great Oaks Way suite 350 alpharetta, GA 30022 |
Supplement Number | Date | Supplement Type |
---|---|---|
P990086 | Original Filing | |
S004 | 2004-02-09 | Normal 180 Day Track No User Fee |
S003 | 2001-11-05 | Panel Track |
S002 | 2001-01-12 | Real-time Process |
S001 | 2000-10-19 | Normal 180 Day Track |