Visi-Pro Balloon-Expandable Peripheral Stent System

Stent, Iliac

FDA Premarket Approval P030045 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Implement new heat sealing equipment.

DeviceVisi-Pro Balloon-Expandable Peripheral Stent System
Classification NameStent, Iliac
Generic NameStent, Iliac
ApplicantMEDTRONIC VASCULAR INC
Date Received2019-05-03
Decision Date2019-05-23
PMAP030045
SupplementS005
Product CodeNIO
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441

Supplemental Filings

Supplement NumberDateSupplement Type
P030045Original Filing
S006 2021-04-08 30-day Notice
S005 2019-05-03 30-day Notice
S004 2017-11-03 30-day Notice
S003
S002 2013-10-30 Normal 180 Day Track
S001 2005-07-18 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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