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R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT

FDA premarket approval P790017/S075 · decided 2001-06-01

Approval details

PMA number
P790017
Supplement
S075
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
2001-03-29
Decision date
2001-06-01
Days to decision
64 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
APPROVAL FOR THE R2L RAPID EXCHANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CATHETERS WITH EXTENDED PRESSURE RANGE. THE DEVICES ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

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