Approval for modification off the labeling to enhance the safety in the use of the products.
| Device | CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS |
| Classification Name | System, Esophageal Pacing |
| Generic Name | System, Esophageal Pacing |
| Applicant | CARDIO COMMAND |
| Date Received | 2009-07-06 |
| Decision Date | 2009-08-18 |
| PMA | P860008 |
| Supplement | S019 |
| Product Code | LPA |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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