Changes to the test program in the software used to determine the roughness of sloping and curved surfaces of the titanium connectors and adapters of the connecting and extension sets for the excor blood pumps
| Device | EXCOR Pediatric Ventricular Assist |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Berlin Heart Inc. |
| Date Received | 2021-09-21 |
| Decision Date | 2021-10-20 |
| PMA | P160035 |
| Supplement | S021 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Berlin Heart Inc. 9391 Grogan's Mill Road, Suite A-6 the Woodlands, TX 77380 |
Supplemental Filings
| 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 |
NIH GUDID Devices