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MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS

FDA premarket approval P870036/S039 · decided 1996-08-30

Approval details

PMA number
P870036
Supplement
S039
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronics Interventional Vascular
Date received
1996-06-24
Decision date
1996-08-30
Days to decision
67 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Santa Rosa, CA
Statement
APPROVAL FOR NEW BALLOON SIZES TO BE ADDED TO THE FALCON 20 CORONARY BALLOON DILATATION CATHETER LINE AND THE ADDTION OF THE FALCON 30 AND FALCON 40 COROANRY BALLOON DILATATION CATHETER LINES. ALSO, SPECIFICATION AND QUALITY CONTROL INSPECTION CHANGES WERE REQUESTED

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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