THERASONIC LITHOTRIPSY TREATMENT SYSTEM
FDA premarket approval P890066/S003 · decided 1992-10-29
Approval details
- PMA number
- P890066
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERASONIC LITHOTRIPSY TREATMENT SYSTEM
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Focus Surgery, Inc.
- Date received
- 1991-11-19
- Decision date
- 1992-10-29
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Milipitas, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.