GENESTONE 190 LITHOTRIPTER
FDA premarket approval P970062 · decided 1998-06-24
Approval details
- PMA number
- P970062
- Trade name
- GENESTONE 190 LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Bmt, Inc.
- Date received
- 1997-12-23
- Decision date
- 1998-06-24
- Days to decision
- 183 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Woodbury, CT
- Statement
- Approval for the Genestone 190 Lithotripter. This device is indicated for use in the non-invasive fragmentation of kidney (renal pelvic and renal calyceal) and upper ureteral stones between 5 and 20mm in size.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.