TRIPTER-X1
FDA premarket approval P920034/S003 · decided 1998-12-14
Approval details
- PMA number
- P920034
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TRIPTER-X1
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medirex, Inc.
- Date received
- 1998-11-12
- Decision date
- 1998-12-14
- Days to decision
- 32 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Wellesley Hills, MA
- Statement
- 1)Contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the Tripter-X1's labeling to reflect the results of this final report.
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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 |