HEALTHTRONICS OSSATRON

Generator, Shock-wave, For Pain Relief

FDA Premarket Approval P990086 S004

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.

Pre-market Approval Supplement Details

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.

DeviceHEALTHTRONICS OSSATRON
Classification NameGenerator, Shock-wave, For Pain Relief
Generic NameGenerator, Shock-wave, For Pain Relief
ApplicantSANUWAVE, INC.
Date Received2004-02-09
Decision Date2004-08-06
PMAP990086
SupplementS004
Product CodeNBN
Advisory CommitteePhysical Medicine
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SANUWAVE, INC. 11680 Great Oaks Way suite 350 alpharetta, GA 30022

Supplemental Filings

Supplement NumberDateSupplement Type
P990086Original 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

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