|
Device | SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) |
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 | S003 |
Date Received | 10/28/2004 |
Decision Date | 09/27/2005 |
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 FOR MODIFICATIONS TO THE POST-APPROVAL PROTOCOL. |