CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625

FDA Premarket Approval P870056

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceCARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
Generic NameReplacement Heart-valve
ApplicantEDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Date Received09/24/1987 Decision Date09/25/1991 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number 91M-0395 Notice Date 11/12/1991 Advisory Committee Cardiovascular Expedited Review Granted? No
Date Received1987-09-24
Decision Date1991-09-25
Notice Date1991-11-12
PMAP870056
SupplementS
Product CodeDYE 
Docket Number91M-0395
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductNo
Applicant AddressEDWARDS LIFESCIENCES, LLC.
one Edwards Way
irvine, CA 92614 PMA NumberP870056 Date Received09/24/1987 Decision Date09/25/1991 Withdrawal Date 01/28/2022 Product Code DYE  Docket Number 91M-0395 Notice Date 11/12/1991 Advisory Committee Cardiovascular Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The Carpentier-Edwards® Bioprosthesis, Models 2625 (aortic) And 6625 (mitral). This Device Is Intended For Use In Patients Whose Aortic Or Mitral Valvular Disease Is Sufficiently Advanced To Warrant Replacement Of Their Natural Valve With A Prosthetic One. It Is Also Intended For Use In Patients With A Previously Implanted Aortic Or Mitral Valve Prosthesis Which Is No Longer Functioning Adequately And Requires Replacement. Supplements:  S002 S003 S006 S010 S011 S012 S013 S014 S015 S016 S017 
S018 S019 S020 S021 S022 S023 S024 S025 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 
S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 
S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 
S067 

Supplemental Filings

Supplement NumberDateSupplement Type
P870056Original Filing
S067 2014-03-05 Real-time Process
S066 2014-02-27 30-day Notice
S065 2014-02-25 30-day Notice
S064 2013-12-24 30-day Notice
S063 2013-11-22 30-day Notice
S062 2013-09-12 30-day Notice
S061 2013-08-26 30-day Notice
S060 2013-06-17 30-day Notice
S059 2013-05-29 30-day Notice
S058 2013-03-25 30-day Notice
S057 2013-02-12 Special (immediate Track)
S056 2012-12-14 Normal 180 Day Track
S055 2012-11-28 135 Review Track For 30-day Notice
S054 2012-11-21 30-day Notice
S053 2012-11-13 30-day Notice
S052 2012-09-04 30-day Notice
S051 2012-08-21 30-day Notice
S050 2012-06-13 30-day Notice
S049 2012-05-04 30-day Notice
S048 2012-03-20 30-day Notice
S047 2012-03-05 Special (immediate Track)
S046 2012-02-21 30-day Notice
S045 2011-12-20 30-day Notice
S044 2011-11-16 30-day Notice
S043 2011-04-08 30-day Notice
S042 2010-12-21 30-day Notice
S041 2010-11-22 30-day Notice
S040 2010-11-12 135 Review Track For 30-day Notice
S039 2010-01-25 30-day Notice
S038 2010-01-21 30-day Notice
S037 2009-12-17 30-day Notice
S036 2009-12-04 30-day Notice
S035 2009-10-19 30-day Notice
S034 2009-07-07 30-day Notice
S033 2009-06-22 30-day Notice
S032 2008-12-08 30-day Notice
S031 2008-11-28 30-day Notice
S030 2008-10-02 30-day Notice
S029 2008-06-20 30-day Notice
S028 2008-03-24 Real-time Process
S027 2007-11-15 30-day Notice
S026
S025 2006-09-26 Real-time Process
S024 2006-08-30 135 Review Track For 30-day Notice
S023 2005-11-14 Special (immediate Track)
S022 2005-08-19 Real-time Process
S021 2005-04-28 30-day Notice
S020 2005-03-21 30-day Notice
S019 2005-01-31 30-day Notice
S018 2004-12-20 30-day Notice
S017 2004-09-27 135 Review Track For 30-day Notice
S016 2002-12-05 30-day Notice
S015 2002-11-12 Normal 180 Day Track
S014 2000-07-13 30-day Notice
S013 2000-05-18 30-day Notice
S012 1999-10-04 30-day Notice
S011 1999-03-26 30-day Notice
S010 1998-10-09 30-day Notice
S009
S008
S007
S006 1998-02-25 Normal 180 Day Track
S005
S004
S003 1996-04-17 Normal 180 Day Track
S002 1995-10-30 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00690103021981 P870056 003
00690103021523 P870056 003
00690103021530 P870056 003
00690103021547 P870056 003
00690103021554 P870056 003
00690103021561 P870056 003
00690103021578 P870056 003
00690103021516 P870056 003
00690103021974 P870056 003
00690103021967 P870056 003
00690103021950 P870056 003
00690103021943 P870056 003
00690103021936 P870056 003
00690103021837 P870056 006
00690103021851 P870056 006
00690103021783 P870056 006
00690103021790 P870056 006
00690103021806 P870056 006
00690103021844 P870056 006
00690103021820 P870056 006
00690103021813 P870056 006

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