ECONOLITH LITHOTRIPTER
FDA premarket approval P950043/S006 · decided 1999-08-27
Approval details
- PMA number
- P950043
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- ECONOLITH LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medispec, Ltd.
- Date received
- 1999-05-19
- Decision date
- 1999-08-27
- Days to decision
- 100 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Montgomery Village, MD
- Statement
- Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe Econolith(TM) Lithotripter's labeling to reflect the results of the final report. Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that the postapproval requirement is now
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Omnispec ED1000 (K210166) | Medispec, Ltd. | 2023-01-27 |
| ECONOLITH EM1000 (K063504) | Medispec, Ltd. | 2007-03-09 |
| ECONOLITH E3000, MODEL 3000 (SW-6) (K040461) | Medispec, Ltd. | 2004-05-25 |
| LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (K974796) | Medispec, Ltd. | 1998-03-12 |