EDAP LT.02 SHOCK WAVE LITHOTRIPTER
FDA premarket approval P880042/S002 · decided 1996-12-18
Approval details
- PMA number
- P880042
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDAP LT.02 SHOCK WAVE LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Edap International Corp.
- Date received
- 1995-05-19
- Decision date
- 1996-12-18
- Days to decision
- 579 days
- Decision code
- APPR
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- APPROVAL FOR A NEW MODEL LITHOTRIPTER, TO BE MANUFACTURED AT THE VAULX-EN-VELIN (FRANCE) FACILITY.
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