SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)
FDA premarket approval P010039/S003 · decided 2005-09-27
Approval details
- PMA number
- P010039
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2004-10-28
- Decision date
- 2005-09-27
- Days to decision
- 334 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL PROTOCOL.
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