|
Device | SIEMENS SONOCUR BASIC SYSTEM |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MALVERN, PA 19355-1406 |
PMA Number | P010039 |
Date Received | 07/27/2001 |
Decision Date | 07/19/2002 |
Withdrawal Date
|
08/05/2016 |
Product Code |
NBN |
Docket Number | 01M-0336 |
Notice Date | 08/06/2002 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SIEMENS SONOCUR BASIC. THE SIEMENS SONOCUR BASIC IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC LATERAL EPICONDYLITIS (COMMONLY REFERRED TO AS TENNIS ELBOW) FOR PATIENTS WITH SYMPTOMS OF CHRONIC LATERAL EPICONDYLITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENTS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S003 |