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 | STAT-PACE II |
| Classification Name | System, Esophageal Pacing |
| Generic Name | System, Esophageal Pacing |
| Applicant | CARDIOCOMMAND, INC. |
| Date Received | 1993-07-12 |
| Decision Date | 1994-01-11 |
| PMA | P840002 |
| Supplement | S001 |
| Product Code | LPA |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIOCOMMAND, INC. 4920 West Cypress Street suite 110 tampa, FL 33607-3837 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840002 | Original Filing | |
| S013 | 2015-05-28 | Normal 180 Day Track No User Fee |
| S012 | 2004-06-04 | Real-time Process |
| S011 | 2004-03-09 | Normal 180 Day Track No User Fee |
| S010 | 2004-01-16 | Normal 180 Day Track No User Fee |
| S009 | 1997-01-21 | Normal 180 Day Track |
| S008 | 1996-01-03 | Normal 180 Day Track |
| S007 | 1995-10-02 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | ||
| S001 | 1993-07-12 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00856233005073 | P840002 | 000 |
| 00856233005158 | P840002 | 007 |
| 00856233005066 | P840002 | 007 |