Carbomedics Prosthetic Heart Valve (CPHV)

FDA Premarket Approval P900060 S063

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 labeling changes which reduce risks and clearly explain how to use a newly designed accessory holder safely

DeviceCarbomedics Prosthetic Heart Valve (CPHV)
Generic NameHeart-valve, Mechanical
ApplicantCORCYM S.r.l.
Date Received2021-08-10
Decision Date2021-09-09
PMAP900060
SupplementS063
Product CodeLWQ 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address CORCYM S.r.l. via Crescentino, Sn saluggia 13040

Supplemental Filings

Supplement NumberDateSupplement Type
P900060Original Filing
S063 2021-08-10 Special (immediate Track)
S062
S061 2020-07-09 135 Review Track For 30-day Notice
S060 2019-07-01 30-day Notice
S059 2018-07-10 30-day Notice
S058 2018-06-15 30-day Notice
S057 2018-04-30 30-day Notice
S056 2017-02-10 30-day Notice
S055
S054 2015-08-10 30-day Notice
S053 2014-01-23 30-day Notice
S052 2013-06-25 30-day Notice
S051 2012-05-23 30-day Notice
S050 2012-05-23 135 Review Track For 30-day Notice
S049 2012-03-27 135 Review Track For 30-day Notice
S048 2012-02-07 30-day Notice
S047 2011-10-31 30-day Notice
S046 2011-08-05 30-day Notice
S045 2011-06-14 30-day Notice
S044 2011-06-02 30-day Notice
S043 2011-06-02 30-day Notice
S042 2011-06-02 30-day Notice
S041 2011-02-28 Real-time Process
S040 2008-05-02 30-day Notice
S039 2007-06-19 Normal 180 Day Track No User Fee
S038 2007-03-27 30-day Notice
S037 2006-10-10 Normal 180 Day Track No User Fee
S036 2006-01-10 30-day Notice
S035 2005-12-16 30-day Notice
S034 2005-09-06 135 Review Track For 30-day Notice
S033 2005-05-26 Normal 180 Day Track No User Fee
S032 2005-05-17 Normal 180 Day Track No User Fee
S031
S030 2005-01-27 135 Review Track For 30-day Notice
S029 2004-06-14 30-day Notice
S028
S027 2003-08-22 30-day Notice
S026 2003-06-27 30-day Notice
S025 2003-05-13 Real-time Process
S024 2002-06-11 Normal 180 Day Track
S023 2002-02-26 Normal 180 Day Track
S022 2001-01-22 30-day Notice
S021 2000-08-07 30-day Notice
S020 1999-07-21 Normal 180 Day Track
S019 1999-05-14 Real-time Process
S018 1998-09-18 Real-time Process
S017 1998-06-01 30-day Notice
S016
S015
S014 1997-05-07 Normal 180 Day Track
S013 1996-02-27 Normal 180 Day Track
S012 1996-02-08 Normal 180 Day Track
S011 1995-05-17 Normal 180 Day Track
S010 1995-02-27 Normal 180 Day Track
S009 1995-01-19 Normal 180 Day Track
S008
S007 1994-12-20 Normal 180 Day Track
S006 1994-08-30 Normal 180 Day Track
S005 1994-04-23 Special (immediate Track)
S004 1994-03-22 Normal 180 Day Track
S003 1994-03-01 Normal 180 Day Track
S002 1993-12-01 Normal 180 Day Track
S001 1993-10-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
08022057014016 P900060 000
08022057012937 P900060 001
08022057012906 P900060 001
08022057012890 P900060 001
08022057012920 P900060 001
08022057012913 P900060 001
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08022057012807 P900060 002
08022057012814 P900060 002
08022057012722 P900060 002
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08022057012746 P900060 002
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08022057012760 P900060 002
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08022057012715 P900060 002
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08022057012593 P900060 002
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08022057012685 P900060 004
08022057012678 P900060 004
08022057012708 P900060 004
08022057012692 P900060 011
08022057013484 P900060 012
08022057013491 P900060 012
08022057013521 P900060 012
08022057013477 P900060 012
08022057013460 P900060 012
08022057013514 P900060 012
08022057013507 P900060 012
08022057012524 P900060 018
08022057012531 P900060 018
08022057012517 P900060 018
08022057012548 P900060 018
08022057012555 P900060 018
08022057012579 P900060 018
08022057012449 P900060 018
08022057012500 P900060 018
08022057012494 P900060 018
08022057012487 P900060 018
08022057012470 P900060 018
08022057012463 P900060 018
08022057012456 P900060 018
08022057012562 P900060 018
08022057012883 P900060 019
08022057012845 P900060 019
08022057012838 P900060 019
08022057012852 P900060 019
08022057012869 P900060 019
08022057012821 P900060 019
08022057012876 P900060 019
08022057013576 P900060 024
08022057013538 P900060 024
08022057013545 P900060 024
08022057013569 P900060 024
08022057013552 P900060 024

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