Abre Venous Self-expanding Stent System

FDA Premarket Approval P200026 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

DeviceAbre Venous Self-expanding Stent System
Generic NameStent, Iliac Vein
ApplicantMedtronic Vascular, Inc.3033 Campus Driveplymouth, MN 55441 PMA NumberP200026 Supplement NumberS005 Date Received06/17/2022 Decision Date07/22/2022 Product Code QAN  Advisory Committee Cardiovascular Clinical TrialsNCT03038438 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Date Received2022-06-17
Decision Date2022-07-22
PMAP200026
SupplementS005
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Vascular, Inc.
3033 Campus Drive
plymouth, MN 55441 PMA NumberP200026 Supplement NumberS005 Date Received06/17/2022 Decision Date07/22/2022 Product Code QAN  Advisory Committee Cardiovascular Clinical TrialsNCT03038438
Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Updates To The Labeling To Include Long-term Results From The ABRE Continued Follow-Up Study

Supplemental Filings

Supplement NumberDateSupplement Type
P200026Original Filing
S005 2022-06-17 Normal 180 Day Track No User Fee
S004 2022-01-28 30-day Notice
S003 2021-10-13 Special (immediate Track)
S002 2021-06-11 30-day Notice
S001 2021-04-08 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00643169796300 P200026 000
00643169796294 P200026 000
00643169796287 P200026 000
00643169796263 P200026 000
00643169796256 P200026 000
00643169796249 P200026 000
00643169796232 P200026 000
00643169796225 P200026 000
00643169796201 P200026 000
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00643169796188 P200026 000
00643169796171 P200026 000
00643169796164 P200026 000
00643169796317 P200026 000
00643169796324 P200026 000
00643169796331 P200026 000
00643169796461 P200026 000
00643169796454 P200026 000
00643169796447 P200026 000
00643169796430 P200026 000
00643169796423 P200026 000
00643169796416 P200026 000
00643169796409 P200026 000
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00643169796386 P200026 000
00643169796379 P200026 000
00643169796362 P200026 000
00643169796355 P200026 000
00643169796348 P200026 000
00643169796157 P200026 000

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