SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
FDA premarket approval P010039/S002 · decided 2003-04-03
Approval details
- PMA number
- P010039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2002-11-13
- Decision date
- 2003-04-03
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Mavern, PA
- 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.
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