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 | ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER |
| Classification Name | System, Esophageal Pacing |
| Generic Name | System, Esophageal Pacing |
| Applicant | CARDIO COMMAND |
| Date Received | 1990-04-12 |
| Decision Date | 1991-03-25 |
| PMA | P860008 |
| Supplement | S009 |
| 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 | CARDIO COMMAND 4920 West Cypress St. Ste.110 tampa, FL 33607 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860008 | Original Filing | |
| S023 | 2017-05-16 | 30-day Notice |
| S022 | 2012-06-18 | 30-day Notice |
| S021 | 2012-02-29 | 135 Review Track For 30-day Notice |
| S020 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S019 | 2009-07-06 | Special (immediate Track) |
| S018 | 2004-06-04 | Real-time Process |
| S017 | 2004-01-16 | Normal 180 Day Track No User Fee |
| S016 | 1998-05-19 | Real-time Process |
| S015 | ||
| S014 | ||
| S013 | ||
| S012 | ||
| S011 | 1991-06-20 | Normal 180 Day Track |
| S010 | 1991-02-20 | Normal 180 Day Track |
| S009 | 1990-04-12 | Normal 180 Day Track |
| S008 | 1989-10-17 | Normal 180 Day Track |
| S007 | 1989-03-16 | Normal 180 Day Track |
| S006 | ||
| S005 | 1988-12-12 | Normal 180 Day Track |
| S004 | ||
| S003 | 1988-07-05 | Special (immediate Track) |
| S002 | 1988-05-13 | Special (immediate Track) |
| S001 | 1987-08-05 | Panel Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00856233005141 | P860008 | 000 |
| 00856233005028 | P860008 | 017 |
| 00856233005035 | P860008 | 017 |
| 00856233005042 | P860008 | 017 |
| 00856233005080 | P860008 | 017 |
| 00856233005196 | P860008 | 018 |
| 00856233005011 | P860008 | 018 |
| 00856233005103 | P860008 | 018 |
| 00856233005110 | P860008 | 018 |
| 00856233005127 | P860008 | 018 |
| 00856233005134 | P860008 | 018 |
| 00856233005165 | P860008 | 018 |
| 00856233005172 | P860008 | 018 |
| 00856233005189 | P860008 | 018 |
| 00856233005004 | P860008 | 018 |