SONOLITH 3000 LITHOTRIPTER
FDA premarket approval P880011/S009 · decided 1997-11-06
Approval details
- PMA number
- P880011
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SONOLITH 3000 LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Edap International Corp.
- Date received
- 1997-10-29
- Decision date
- 1997-11-06
- Days to decision
- 8 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
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