CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS

FDA Premarket Approval P870056 S061

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

DeviceCARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS
Generic NameReplacement Heart-valve
ApplicantEDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS061 Date Received08/26/2013 Decision Date09/23/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2013-08-26
Decision Date2013-09-23
PMAP870056
SupplementS061
Product CodeDYE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressEDWARDS LIFESCIENCES, LLC.
one Edwards Way
irvine, CA 92614 PMA NumberP870056 Supplement NumberS061 Date Received08/26/2013 Decision Date09/23/2013 Withdrawal Date 01/28/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
CHANGING THE SILICONE GASKET MATERIAL (SUPPLIED BY ST. GOBAIN) FOR THE 3.8 OZ. JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR ALL EDWARDS HEART VALVES.

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.