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 BIOPROSTHETIC VALVED CONDUIT |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS006 Date Received02/25/1998 Decision Date08/07/1998 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 1998-02-25 |
| Decision Date | 1998-08-07 |
| PMA | P870056 |
| Supplement | S006 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 PMA NumberP870056 Supplement NumberS006 Date Received02/25/1998 Decision Date08/07/1998 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Adding The Model 4300 Valved Conduit And Is Indicated For Correction Of Pulmonary Stenosis Or Atresia And Complex Congenital Malformations Requiring Rastelli-type Operations, And For Correction Of Tricuspid Atresia. |
| 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 |