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MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS

FDA premarket approval P870036/S038 · decided 1996-09-25

Approval details

PMA number
P870036
Supplement
S038
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronics Interventional Vascular
Date received
1996-04-16
Decision date
1996-09-25
Days to decision
162 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Santa Rosa, CA
Statement
APPROVAL FOR THE INTRODUCTION OF A NEW PRODUCT LINE. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MILLENIA CORONARY BALLOON DILATATION CATHETER

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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