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MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM

FDA premarket approval P960010/S001 · decided 1998-05-21

Approval details

PMA number
P960010
Supplement
S001
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronics Interventional Vascular
Date received
1997-11-25
Decision date
1998-05-21
Days to decision
177 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Santa Rosa, CA
Statement
Approval for the Medtronic Model 6322 Wiktor(R) Rival(TM) Coronary Stent 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 grafts vessels with reference diameters in the range of 3.0 to 4.5mm.

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510(k) clearances by this applicant

RecordFirmDate
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (K990707)Medtronics Interventional Vascular1999-03-22
MEDTRONIC ANGIOGRAPHIC CATHETER (K980973)Medtronics Interventional Vascular1998-12-10
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (K982883)Medtronics Interventional Vascular1998-09-04
MEDTRONIC ZUMA GUIDING CATHETER (K981198)Medtronics Interventional Vascular1998-08-07
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT (K972944)Medtronics Interventional Vascular1997-11-03
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917)Medtronics Interventional Vascular1996-11-20
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983)Medtronics Interventional Vascular1996-05-30
MEDTRONIC SHERPA GUIDING CATHETER (K955651)Medtronics Interventional Vascular1996-01-22