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 VALVED CONDUIT, MODEL 4300 |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS047 Date Received03/05/2012 Decision Date04/04/2012 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2012-03-05 |
| Decision Date | 2012-04-04 |
| PMA | P870056 |
| Supplement | S047 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614 PMA NumberP870056 Supplement NumberS047 Date Received03/05/2012 Decision Date04/04/2012 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL FOR ADDING TEXT TO THE WARNINGS AND COMPLICATIONS SECTIONS OF THE EDWARDS MODEL 4300 VALVED CONDUIT IFU IN ORDER TO STRENGTHEN THESE STATEMENTS. |
| 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 |