Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-eluting Stent

FDA Premarket Approval P150023 S009

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

Extend the retest period from 60 months to 96 months for everolimus repackaged in configuration i.

DeviceAbsorb GTi Bioresorbable Vascular Scaffold (BVS) System
Classification NameAbsorbable Coronary Drug-eluting Stent
Generic NameAbsorbable Coronary Drug-eluting Stent
ApplicantABBOTT VASCULAR INC.
Date Received2017-05-17
Decision Date2017-06-23
PMAP150023
SupplementS009
Product CodePNY
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P150023Original Filing
S010 2018-03-01 Normal 180 Day Track
S009 2017-05-17 30-day Notice
S008 2017-04-14 30-day Notice
S007 2017-03-13 135 Review Track For 30-day Notice
S006 2016-10-24 30-day Notice
S005 2016-09-08 30-day Notice
S004
S003 2016-08-05 Normal 180 Day Track No User Fee
S002 2016-07-29 Special (immediate Track)
S001 2016-07-11 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.