TRIPTER-X1 Nova
FDA premarket approval P920034 · Lithotriptor, extracorporeal shock-wave, urological
PMA numberP920034
Approval
- Applicant
- Medirex, Inc.
- Received
- July 9, 1992
- Decision date
- September 20, 1996 (APRL)
- Supplements
- 3, latest December 14, 1998
- Product code
- LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological
Approval order statement
APPROVAL FOR THE TRIPTER-X1 SERIES EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERS (TRIPTER-X1, TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT