HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
FDA premarket approval P970019 · decided 1997-07-21
Approval details
- PMA number
- P970019
- Trade name
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Healthtronics Surgical Services, Inc.
- Date received
- 1997-05-16
- Decision date
- 1997-07-21
- Days to decision
- 66 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marietta, GA
- Statement
- APPROVAL FOR THE LITHOTRON(TM) LITHOTRIPSY SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH RENAL AND UPPER URETERAL CALCULI BETWEEN 4 AND 20 MM IN SIZE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TWINTRODE ELC 134 ELECTRODE (K012785) | Healthtronics Surgical Services, Inc. | 2001-11-16 |
| HEALTHTRONIC OMEGA TRAC (K881902) | Healthtronics Surgical Services, Inc. | 1988-06-22 |