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 PERIMOUNT PORCINE BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT PORCIN MITRAL BIOPROSTHESIS |
| Generic Name | Replacement Heart-valve |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP870056 Supplement NumberS028 Date Received03/24/2008 Decision Date05/23/2008 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-05-23 |
| PMA | P870056 |
| Supplement | S028 |
| Product Code | DYE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 NumberS028 Date Received03/24/2008 Decision Date05/23/2008 Withdrawal Date 01/28/2022 Product Code DYE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS. |
| 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 |