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GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER

FDA premarket approval P790017/S086 · decided 2007-08-17

Approval details

PMA number
P790017
Supplement
S086
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
2006-12-04
Decision date
2007-08-17
Days to decision
256 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
APPROVAL TO: 1) INTRODUCE AN AUTOMATED INFLATION DEVICE, REPLACING THE CURRENT MANUAL PROCESS, TO INFLATE PTCA BALLOONS PRIOR TO IN-PROCESS FUNCTIONAL TESTING; AND 2) REDUCE THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.

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