PMA P990086

Device: HEALTHTRONICS OSSATRON
Applicant: Sanuwave, Inc.
PMA number: P990086
Supplement: S004
Product code: NBN
Decision date: 2004-08-06
Classification: Generator, Shock-wave, For Pain Relief
Generic name: Generator, shock-wave, for pain relief
Approval order statement: 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.

Current openFDA PMA Record#

Device: HEALTHTRONICS OSSATRON
Applicant: Sanuwave, Inc.
PMA number: P990086
Supplement: S004
Product code: NBN
Generic name: Generator, shock-wave, for pain relief
Decision date: 2004-08-06
Decision code: APPR
Date received: 2004-02-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 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.