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D114S OTW BALLOON DILATATION CATHETER

FDA premarket approval P790017/S074 · decided 2001-01-08

Approval details

PMA number
P790017
Supplement
S074
Supplement type
Real-Time Process
Supplement reason
Other
Trade name
D114S OTW BALLOON DILATATION CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
2000-09-14
Decision date
2001-01-08
Days to decision
116 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
APPROVAL FOR THE ADDITION OF SIX (6) CATALOGUE ITEMS TO THE APPROVED D114S OVER-THE-WIRE BALLOON DILATATION CATHETER PRODUCT LINE. THESE SIX ITEMS CONSIST OF A 10 MM BALLOON LENGTH IN EACH OF THE CURRENT BALLOON DIAMETERS OF 1.5 MM, 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, AND 4.0 MM. IN ADDITION, APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO THE 1.5 MM DIAMETER EXTRUDED BALLOON TUBING (0.0135"/0.0205" ID/OD FROM THE CURRENT 0.014"/0.022" ID/OD. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC

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