Abre Venous self-expanding stent system

FDA Premarket Approval P200026 S003

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

Updates to the instructions for use (ifu) to provide clarifications and new information regarding vessel measurement and stent selection

DeviceAbre Venous self-expanding stent system
Generic NameStent, Iliac Vein
ApplicantMedtronic Vascular, Inc.
Date Received2021-10-13
Decision Date2021-11-05
PMAP200026
SupplementS003
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Vascular, Inc. 3033 Campus Drive plymouth, MN 55441

Supplemental Filings

Supplement NumberDateSupplement Type
P200026Original Filing
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
00643169796195 P200026 000
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
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00643169796362 P200026 000
00643169796355 P200026 000
00643169796348 P200026 000
00643169796157 P200026 000

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