Changes to the quality control testing of titanium connectors.
| Device | EXCOR Pediatric Ventricular Assist |
| Classification Name | Ventricular (assist) Bypass |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Berlin Heart Inc. |
| Date Received | 2018-09-28 |
| Decision Date | 2018-10-26 |
| PMA | P160035 |
| Supplement | S004 |
| Product Code | DSQ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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