ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-eluting Stent

FDA Premarket Approval P150023 S001

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 for a shelf life extension from 12 months to 18 months for the small scaffold design (2. 5 and 3. 0mm diameters), and the implementation of an alternate temperature monitoring system.

DeviceABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Classification NameAbsorbable Coronary Drug-eluting Stent
Generic NameAbsorbable Coronary Drug-eluting Stent
ApplicantABBOTT VASCULAR INC.
Date Received2016-07-11
Decision Date2016-10-07
PMAP150023
SupplementS001
Product CodePNY
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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

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