lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System

FDA Premarket Approval P030045 S006

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

Approval of a new sterilization cycle with a reduced eo concentration using chamber 31 and chamber 32 at contract sterilizer

• Device: lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System
• Generic Name: Stent, Iliac
• Applicant: MEDTRONIC VASCULAR INC
• Date Received: 2021-04-08
• Decision Date: 2021-05-07
• PMA: P030045
• Supplement: S006
• Product Code: NIO
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: MEDTRONIC VASCULAR INC 3033 Campus Drive plymouth, MN 55441

Supplemental Filings

Supplement Number	Date	Supplement Type
P030045		Original 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 ID	PMA	Supp
00643169787568	P030045	002
00643169787704	P030045	002
00643169787711	P030045	002
00643169787728	P030045	002
00643169787735	P030045	002
00643169787742	P030045	002
00643169787759	P030045	002
00643169787766	P030045	002
00643169787773	P030045	002
00643169787780	P030045	002
00643169787797	P030045	002
00643169787698	P030045	002
00643169787681	P030045	002
00643169787674	P030045	002
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00643169787612	P030045	002
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00643169787650	P030045	002
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00643169787995	P030045	002
00643169788008	P030045	002
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00643169788022	P030045	002
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00643169788046	P030045	002
00643169788053	P030045	002
00643169787957	P030045	002
00643169787940	P030045	002
00643169787933	P030045	002
00643169787834	P030045	002
00643169787841	P030045	002
00643169787858	P030045	002
00643169787865	P030045	002
00643169787872	P030045	002
00643169787889	P030045	002
00643169787896	P030045	002
00643169787902	P030045	002
00643169787919	P030045	002
00643169787926	P030045	002
00643169788060	P030045	002