MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
FDA premarket approval P960010 · decided 1997-06-27
Approval details
- PMA number
- P960010
- Trade name
- MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronics Interventional Vascular
- Date received
- 1996-05-01
- Decision date
- 1997-06-27
- Days to decision
- 422 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE MEDTRONIC WIKTOR(R) PRIME CORONARY STENT DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN NATIVE CORONARY ARTERIES AND BYPASS GRAFT VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 3.0 TO 4.5 MM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (K990707) | Medtronics Interventional Vascular | 1999-03-22 |
| MEDTRONIC ANGIOGRAPHIC CATHETER (K980973) | Medtronics Interventional Vascular | 1998-12-10 |
| MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (K982883) | Medtronics Interventional Vascular | 1998-09-04 |
| MEDTRONIC ZUMA GUIDING CATHETER (K981198) | Medtronics Interventional Vascular | 1998-08-07 |
| MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT (K972944) | Medtronics Interventional Vascular | 1997-11-03 |
| MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917) | Medtronics Interventional Vascular | 1996-11-20 |
| MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983) | Medtronics Interventional Vascular | 1996-05-30 |
| MEDTRONIC SHERPA GUIDING CATHETER (K955651) | Medtronics Interventional Vascular | 1996-01-22 |