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.
| Device | CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS 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 Received | 2013-08-26 |
| Decision Date | 2013-09-23 |
| PMA | P870056 |
| Supplement | S061 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870056 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |