Approval for the interchangeability of existing approved products. Those products are external pulse generators (models 2a, 7a, and 7b) and esophageal catheter systems (models 205, 210, 210s, 1600, 500 series, and tapsul. )
| Device | EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR |
| Classification Name | System, Esophageal Pacing |
| Generic Name | System, Esophageal Pacing |
| Applicant | CARDIO COMMAND |
| Date Received | 2004-06-04 |
| Decision Date | 2004-08-27 |
| PMA | P860008 |
| Supplement | S018 |
| Product Code | LPA |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices