MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Heart-valve, Mechanical

FDA Premarket Approval P790018 S010

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

DeviceMEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Classification NameHeart-valve, Mechanical
Generic NameHeart-valve, Mechanical
ApplicantMEDTRONIC CARDIAC SURGERY
Date Received1984-05-02
Decision Date1985-02-08
PMAP790018
SupplementS010
Product CodeLWQ
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC CARDIAC SURGERY 8299 Central Ave., N.e. spring Lake Park, MN 55432-3576

Supplemental Filings

Supplement NumberDateSupplement Type
P790018Original Filing
S052 2009-06-09 30-day Notice
S051 2009-02-24 Special (immediate Track)
S050 2008-11-10 30-day Notice
S049 2008-08-11 30-day Notice
S048 2008-05-27 30-day Notice
S047 2006-12-26 30-day Notice
S046 2006-05-10 135 Review Track For 30-day Notice
S045 2003-11-12 Normal 180 Day Track No User Fee
S044 2003-08-29 30-day Notice
S043 2002-03-22 Normal 180 Day Track
S042 2001-12-26 Special (immediate Track)
S041 2001-11-19 Normal 180 Day Track
S040 2001-11-19 30-day Notice
S039 2001-11-05 Normal 180 Day Track
S038 2001-11-05 Special (immediate Track)
S037 2001-04-19 Real-time Process
S036 2000-10-17 30-day Notice
S035 1999-08-31 Normal 180 Day Track
S034 1998-10-27 30-day Notice
S033 1998-07-14 Normal 180 Day Track
S032 1998-01-30 Normal 180 Day Track
S031 1997-07-21 Normal 180 Day Track
S030 1997-03-13 Normal 180 Day Track
S029 1997-02-21 Normal 180 Day Track
S028 1996-07-23 Normal 180 Day Track
S027
S026 1995-11-01 Normal 180 Day Track
S025 1995-02-27 Normal 180 Day Track
S024 1995-01-18 Normal 180 Day Track
S023 1994-03-25 Normal 180 Day Track
S022 1993-09-23 Normal 180 Day Track
S021 1993-01-06 Normal 180 Day Track
S020 1992-04-16 Normal 180 Day Track
S019 1992-05-26 Normal 180 Day Track
S018 1992-01-10 Special (immediate Track)
S017 1991-12-10 Normal 180 Day Track
S016 1989-05-08 Normal 180 Day Track
S015
S014 1985-12-06
S013 1985-12-04
S012 1984-12-06
S011
S010 1984-05-02
S009
S008 1983-09-22
S007 1984-02-29
S006 1983-12-07
S005 1983-06-13
S004 1982-11-24
S003 1982-07-29
S002 1982-02-12
S001 1982-02-02

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