THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

FDA Premarket Approval P870072 S040

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 to strengthen the ivad y-connector termination by adding a small amount (35 ul) of silicone oil to the inner wall of the pneumatic line to reduce the transferable force between the ivad optical sensor cable and the pneumatic line wall.

DeviceTHORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE
Generic NameVentricular (assist) Bypass
ApplicantTHORATEC LABORATORIES CORP.
Date Received2008-04-21
Decision Date2008-10-31
PMAP870072
SupplementS040
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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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