PMA P010039S002

Device: SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P010039
Supplement: S002
Product code: NBN
Decision date: 2003-04-03
Classification: General, Plastic Surgery
Generic name: Generator, shock-wave, for pain relief
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.

Current openFDA PMA Record#

Device: SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P010039
Supplement: S002
Product code: NBN
Generic name: Generator, shock-wave, for pain relief
Decision date: 2003-04-03
Decision code: APPR
Date received: 2002-11-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.