HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
FDA premarket approval P970019/S003 · decided 1998-11-18
Approval details
- PMA number
- P970019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Healthtronics Surgical Services, Inc.
- Date received
- 1998-07-23
- Decision date
- 1998-11-18
- Days to decision
- 118 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marietta, GA
- Statement
- Approval for modifications to the LithoTron(TM) Lithotripsy System's labeling to reflect the results of this 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 this postapproval requirement is now considered complete.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |