This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 |
| Classification Name | System, Esophageal Pacing |
| Generic Name | System, Esophageal Pacing |
| Applicant | CARDIO COMMAND |
| Date Received | 1986-03-17 |
| Decision Date | 1986-12-30 |
| Notice Date | 1987-02-25 |
| PMA | P860008 |
| Supplement | S |
| Product Code | LPA |
| Docket Number | 87M-0009 |
| Advisory Committee | Cardiovascular |
| 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 |