MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
FDA premarket approval P870036/S042 · decided 1997-07-28
Approval details
- PMA number
- P870036
- Supplement
- S042
- Trade name
- MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronics Interventional Vascular
- Date received
- 1997-01-29
- Decision date
- 1997-07-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.
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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 |