ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-eluting Stent

FDA Premarket Approval P150023 S002

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 labeling changes to clarify the interpretation of the absorb iii clinical data for geriatric patients in the absorb gt1 bvs instructions for use.

DeviceABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Classification NameAbsorbable Coronary Drug-eluting Stent
Generic NameAbsorbable Coronary Drug-eluting Stent
ApplicantABBOTT VASCULAR INC.
Date Received2016-07-29
Decision Date2016-08-25
PMAP150023
SupplementS002
Product CodePNY
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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