TECHNOMED INTERNATIONAL SONOLITH 2000
FDA premarket approval P880011/S003 · decided 1995-09-06
Approval details
- PMA number
- P880011
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECHNOMED INTERNATIONAL SONOLITH 2000
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Edap International Corp.
- Date received
- 1990-09-11
- Decision date
- 1995-09-06
- Days to decision
- 1821 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Burlington, MA
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