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.
Approval for the excor® pediatric ventricular assist device (referred to as excor pediatric) is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the excor pediatric.
| Device | EXCOR Pediatric Ventricular Assist |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Berlin Heart Inc. |
| Date Received | 2016-08-11 |
| Decision Date | 2017-06-06 |
| Notice Date | 2017-06-09 |
| PMA | P160035 |
| Supplement | S |
| Product Code | DSQ |
| Docket Number | 17M-3580 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Berlin Heart Inc. 9391 Grogan's Mill Road, Suite A-6 the Woodlands, TX 77380 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160035 | Original Filing | |
| S031 | 2022-08-02 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2022-07-15 | 30-day Notice |
| S027 | 2022-07-05 | 30-day Notice |
| S026 | 2022-05-16 | 30-day Notice |
| S025 | ||
| S024 | 2021-11-08 | 135 Review Track For 30-day Notice |
| S023 | 2021-10-20 | 30-day Notice |
| S022 | 2021-10-04 | 30-day Notice |
| S021 | 2021-09-21 | 30-day Notice |
| S020 | 2021-09-17 | 30-day Notice |
| S019 | 2020-12-14 | 30-day Notice |
| S018 | 2020-09-28 | 30-day Notice |
| S017 | 2020-09-24 | 30-day Notice |
| S016 | ||
| S015 | 2020-08-05 | 30-day Notice |
| S014 | 2020-04-06 | 30-day Notice |
| S013 | ||
| S012 | 2019-10-11 | 30-day Notice |
| S011 | 2019-10-11 | 30-day Notice |
| S010 | ||
| S009 | 2019-09-26 | 30-day Notice |
| S008 | ||
| S007 | 2019-06-20 | Normal 180 Day Track |
| S006 | ||
| S005 | 2019-04-10 | Real-time Process |
| S004 | 2018-09-28 | 30-day Notice |
| S003 | 2018-01-05 | 30-day Notice |
| S002 | 2017-07-14 | 30-day Notice |
| S001 | 2017-06-29 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 04260090041352 | P160035 | 001 |
| 04260090041369 | P160035 | 001 |
| 04260090040379 | P160035 | 002 |
| 04260090040386 | P160035 | 002 |
| 04260090040508 | P160035 | 002 |
| 04260090040539 | P160035 | 002 |
| 04260090041277 | P160035 | 002 |
| 04260090041284 | P160035 | 002 |
| 04260090041291 | P160035 | 002 |
| 04260090041307 | P160035 | 002 |
| 04260090041321 | P160035 | 002 |
| 04260090041338 | P160035 | 002 |
| 04260090041352 | P160035 | 002 |
| 04260090041369 | P160035 | 002 |