MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
FDA premarket approval P870036/S043 · decided 1997-08-12
Approval details
- PMA number
- P870036
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronics Interventional Vascular
- Date received
- 1997-03-03
- Decision date
- 1997-08-12
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR TH
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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 |