TRIPTER-X1 NOVA
FDA premarket approval P920034 · decided 1996-09-20
Approval details
- PMA number
- P920034
- Trade name
- TRIPTER-X1 NOVA
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medirex, Inc.
- Date received
- 1992-07-09
- Decision date
- 1996-09-20
- Days to decision
- 1534 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Wellesley Hills, MA
- Statement
- APPROVAL FOR THE TRIPTER-X1 SERIES EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERS (TRIPTER-X1, TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DIGISCOPE RX-2 (9 OPTION) (K965013) | Medirex, Inc. | 1997-01-17 |
| IPU RX-2 (K964327) | Medirex, Inc. | 1997-01-17 |
| DIGISCOPE RX-2 (K960198) | Medirex, Inc. | 1996-03-12 |