TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
FDA premarket approval P920034/S001 · decided 1997-03-26
Approval details
- PMA number
- P920034
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medirex, Inc.
- Date received
- 1997-03-18
- Decision date
- 1997-03-26
- Days to decision
- 8 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Wellesley Hills, MA
- Statement
- APPROVAL FOR LABELING CHANGES DESCRIBING THE TRANSPORTABILITY OF THE DEVICE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |