This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P960006S011 |
| Classification Name | None |
| Applicant | |
| PMA | P960006 |
| Supplement | S011 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960006 | Original Filing | |
| S055 | 2022-11-01 | 30-day Notice |
| S054 | 2021-09-30 | 30-day Notice |
| S053 | 2021-09-01 | 30-day Notice |
| S052 | 2021-04-30 | 30-day Notice |
| S051 | 2021-03-08 | 30-day Notice |
| S050 | 2021-01-11 | 30-day Notice |
| S049 | 2019-03-13 | 30-day Notice |
| S048 | 2018-07-13 | 30-day Notice |
| S047 | 2018-03-26 | 30-day Notice |
| S046 | 2016-05-27 | 30-day Notice |
| S045 | ||
| S044 | 2015-06-22 | 30-day Notice |
| S043 | 2014-06-30 | 30-day Notice |
| S042 | 2014-04-22 | 30-day Notice |
| S041 | 2014-01-28 | Real-time Process |
| S040 | 2013-08-29 | 30-day Notice |
| S039 | 2013-05-16 | Real-time Process |
| S038 | 2013-03-19 | Real-time Process |
| S037 | 2012-11-08 | 30-day Notice |
| S036 | 2012-10-02 | 30-day Notice |
| S035 | 2012-09-04 | 30-day Notice |
| S034 | 2012-06-19 | 30-day Notice |
| S033 | 2012-03-26 | 30-day Notice |
| S032 | 2012-01-24 | 30-day Notice |
| S031 | 2011-05-25 | 30-day Notice |
| S030 | 2011-04-01 | 30-day Notice |
| S029 | 2010-12-01 | 135 Review Track For 30-day Notice |
| S028 | ||
| S027 | 2010-09-21 | 30-day Notice |
| S026 | 2009-12-18 | 30-day Notice |
| S025 | 2009-12-16 | 30-day Notice |
| S024 | ||
| S023 | ||
| S022 | 2007-05-07 | 30-day Notice |
| S021 | 2006-04-13 | 30-day Notice |
| S020 | 2006-04-13 | 30-day Notice |
| S019 | 2005-11-09 | 30-day Notice |
| S018 | ||
| S017 | 2005-08-01 | 30-day Notice |
| S016 | 2005-07-05 | 30-day Notice |
| S015 | 2005-04-13 | 30-day Notice |
| S014 | 2005-02-24 | 30-day Notice |
| S013 | 2004-12-03 | 30-day Notice |
| S012 | 2004-10-21 | 30-day Notice |
| S011 | ||
| S010 | 2004-04-14 | 30-day Notice |
| S009 | 2004-01-13 | 30-day Notice |
| S008 | 2003-03-20 | Real-time Process |
| S007 | 2002-11-13 | 30-day Notice |
| S006 | ||
| S005 | 2001-07-11 | Normal 180 Day Track |
| S004 | 2000-08-21 | Normal 180 Day Track |
| S003 | 1999-12-16 | Normal 180 Day Track |
| S002 | 1998-10-29 | Real-time Process |
| S001 | 1998-10-02 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00802526489419 | P960006 | 005 |
| 00802526397745 | P960006 | 015 |
| 00802526397738 | P960006 | 015 |
| 00802526397721 | P960006 | 015 |
| 00802526064043 | P960006 | 039 |