TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P070027 S024

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 of the post-approval study protocol.

DeviceTALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantMedtronic Vascular
Date Received2010-11-01
Decision Date2010-12-08
PMAP070027
SupplementS024
Product CodeMIH
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P070027Original Filing
S048 2016-08-17 135 Review Track For 30-day Notice
S047 2016-07-13 30-day Notice
S046 2015-09-24 30-day Notice
S045 2015-09-18 30-day Notice
S044 2015-08-31 135 Review Track For 30-day Notice
S043 2015-07-31 30-day Notice
S042
S041 2015-03-20 135 Review Track For 30-day Notice
S040 2014-03-11 30-day Notice
S039 2014-02-24 Normal 180 Day Track No User Fee
S038 2014-01-31 30-day Notice
S037 2013-12-16 30-day Notice
S036 2013-04-04 30-day Notice
S035 2012-08-24 30-day Notice
S034 2012-03-22 135 Review Track For 30-day Notice
S033 2011-09-30 30-day Notice
S032 2011-09-20 Normal 180 Day Track No User Fee
S031 2011-08-12 30-day Notice
S030 2011-06-14 30-day Notice
S029 2011-02-14 135 Review Track For 30-day Notice
S028 2011-01-12 30-day Notice
S027 2010-12-10 135 Review Track For 30-day Notice
S026 2010-12-06 30-day Notice
S025 2010-11-10 Normal 180 Day Track No User Fee
S024 2010-11-01 Normal 180 Day Track No User Fee
S023 2010-10-07 30-day Notice
S022 2010-10-01 30-day Notice
S021
S020 2010-06-10 30-day Notice
S019 2010-06-04 30-day Notice
S018 2010-05-05 Normal 180 Day Track No User Fee
S017 2010-05-03 Normal 180 Day Track No User Fee
S016 2010-03-12 Real-time Process
S015 2010-03-03 Normal 180 Day Track No User Fee
S014 2009-11-20 30-day Notice
S013 2009-11-18 30-day Notice
S012 2009-09-17 Normal 180 Day Track No User Fee
S011 2009-08-10 Normal 180 Day Track
S010 2009-08-04 30-day Notice
S009 2009-06-02 135 Review Track For 30-day Notice
S008 2009-02-18 30-day Notice
S007 2009-02-13 30-day Notice
S006 2009-01-15 Normal 180 Day Track No User Fee
S005 2008-12-19 Normal 180 Day Track No User Fee
S004 2008-09-12 Normal 180 Day Track No User Fee
S003 2008-08-18 135 Review Track For 30-day Notice
S002 2008-05-15 Normal 180 Day Track No User Fee
S001 2008-05-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994542601 P070027 006
00613994542519 P070027 006
00613994542663 P070027 006
00613994542724 P070027 006
00613994545619 P070027 006
00613994542489 P070027 006
00613994542540 P070027 006
00613994386199 P070027 011
00613994386175 P070027 011
00613994386151 P070027 011
00613994386137 P070027 011
00613994386120 P070027 011
00613994386106 P070027 011
00613994386212 P070027 011
00613994573186 P070027 011
00613994573162 P070027 011
00613994573148 P070027 011
00613994573124 P070027 011
00613994573100 P070027 011
00613994573087 P070027 011
00613994573063 P070027 011
00613994573049 P070027 011
00613994573025 P070027 011
00613994386083 P070027 011

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