MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

FDA Premarket Approval P790018 S045

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 a manufacturing site located at biotest laboratories, inc. Minneapolis, minnesota.

DeviceMEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT
Generic NameHeart-valve, Mechanical
ApplicantMEDTRONIC CARDIAC SURGERY
Date Received2003-11-12
Decision Date2003-11-28
PMAP790018
SupplementS045
Product CodeLWQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonExpress Gmp Supplement
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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