|
Device | SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) 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 |
Supplement Number | S002 |
Date Received | 11/13/2002 |
Decision Date | 04/03/2003 |
Withdrawal Date
|
08/05/2016 |
Product Code |
NBN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE JULY, 19, 2002 APPROVAL ORDER FOR P010039. |
Post-Approval Study | Show Report Schedule and Study Progress |