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THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER

FDA premarket approval P870036/S044 · decided 1998-11-17

Approval details

PMA number
P870036
Supplement
S044
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronics Interventional Vascular
Date received
1998-05-20
Decision date
1998-11-17
Days to decision
181 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Santa Rosa, CA
Statement
Approval for a new product line. The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) Coronary Balloon Dilatation Catheter and is 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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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
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MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983)Medtronics Interventional Vascular1996-05-30
MEDTRONIC SHERPA GUIDING CATHETER (K955651)Medtronics Interventional Vascular1996-01-22