THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Ventricular (assist) Bypass

FDA Premarket Approval P870072 S015

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 the issuance of technical bulletin #009.

DeviceTHORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification NameVentricular (assist) Bypass
Generic NameVentricular (assist) Bypass
ApplicantTHORATEC LABORATORIES CORP.
Date Received2001-06-07
Decision Date2001-11-30
PMAP870072
SupplementS015
Product CodeDSQ
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address THORATEC LABORATORIES CORP. 2023 Eighth St. berkeley, CA 94710

Supplemental Filings

Supplement NumberDateSupplement Type
P870072Original Filing
S062 2016-05-16 30-day Notice
S061 2015-12-23 30-day Notice
S060 2015-05-07 30-day Notice
S059 2014-02-18 30-day Notice
S058 2013-11-26 30-day Notice
S057 2013-11-21 Special (immediate Track)
S056 2013-07-05 30-day Notice
S055 2013-07-02 Normal 180 Day Track
S054 2013-05-16 Normal 180 Day Track
S053 2013-04-22 Real-time Process
S052 2013-02-28 30-day Notice
S051 2012-10-31 30-day Notice
S050 2012-10-03 Normal 180 Day Track
S049 2012-05-30 30-day Notice
S048 2012-05-21 30-day Notice
S047 2011-02-11 30-day Notice
S046 2010-12-27 Normal 180 Day Track No User Fee
S045 2010-09-14 Real-time Process
S044 2010-08-18 Normal 180 Day Track
S043 2010-02-12 Real-time Process
S042 2009-09-04 Real-time Process
S041 2009-02-23 Normal 180 Day Track No User Fee
S040 2008-04-21 Real-time Process
S039 2007-12-27 Special (immediate Track)
S038
S037 2007-07-30 Real-time Process
S036 2007-04-16 Real-time Process
S035 2006-09-14 Normal 180 Day Track
S034 2006-07-12 Real-time Process
S033 2004-12-27 Normal 180 Day Track No User Fee
S032
S031 2004-10-28 30-day Notice
S030 2004-09-29 Real-time Process
S029 2004-02-23 Normal 180 Day Track No User Fee
S028 2004-03-03 Real-time Process
S027 2004-01-06 Normal 180 Day Track
S026 2003-07-03 Real-time Process
S025 2003-03-10 Real-time Process
S024 2002-12-11 Special (immediate Track)
S023 2002-12-03 Normal 180 Day Track
S022 2002-09-30 Special (immediate Track)
S021 2002-09-06 Normal 180 Day Track
S020 2002-08-16 Normal 180 Day Track
S019 2002-03-27 Special (immediate Track)
S018 2001-10-22 Normal 180 Day Track
S017 2001-08-01 Normal 180 Day Track
S016 2001-06-29 Normal 180 Day Track
S015 2001-06-07 Normal 180 Day Track
S014
S013 2000-10-30 Normal 180 Day Track
S012 2000-09-25 Normal 180 Day Track
S011 2000-04-24 Normal 180 Day Track
S010 2000-04-11 Normal 180 Day Track
S009 1998-11-17 Normal 180 Day Track
S008
S007 1998-07-13 30-day Notice
S006 1997-12-22 Normal 180 Day Track
S005 1997-10-06 Panel Track
S004 1997-05-28 Real-time Process
S003 1996-10-18 Normal 180 Day Track
S002 1996-04-08 Special (immediate Track)
S001 1996-01-30 Normal 180 Day Track

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