This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.
| Device | P950027S008 |
| Classification Name | None |
| Applicant | |
| PMA | P950027 |
| Supplement | S008 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950027 | Original Filing | |
| S018 | 2022-12-23 | 30-day Notice |
| S017 | 2022-09-08 | 30-day Notice |
| S016 | 2022-07-11 | 30-day Notice |
| S015 | 2016-08-01 | 30-day Notice |
| S014 | 2013-08-29 | Real-time Process |
| S013 | ||
| S012 | 2010-02-26 | 30-day Notice |
| S011 | 2008-02-20 | Real-time Process |
| S010 | 2007-12-07 | Special (immediate Track) |
| S009 | 2007-06-20 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 2005-01-07 | Real-time Process |
| S005 | ||
| S004 | 1998-12-23 | Normal 180 Day Track |
| S003 | 1998-08-24 | Normal 180 Day Track |
| S002 | 1998-08-05 | Normal 180 Day Track |
| S001 | 1997-06-24 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| M71389122072420A1 | P950027 | 006 |
| M71389122072412A1 | P950027 | 006 |
| M713891220724120 | P950027 | 006 |
| M713891220724200 | P950027 | 006 |
| 05060459970052 | P950027 | 014 |