This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | EXCOR® Pediatric Ventricular Assist |
| Generic Name | Ventricular (assist) Bypass |
| Applicant | Berlin Heart Inc.9391 Grogan's Mill Road, Suite A-6the Woodlands, TX 77380 PMA NumberP160035 Supplement NumberS024 Date Received11/08/2021 Decision Date03/04/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-11-08 |
| Decision Date | 2022-03-04 |
| PMA | P160035 |
| Supplement | S024 |
| Product Code | DSQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 PMA NumberP160035 Supplement NumberS024 Date Received11/08/2021 Decision Date03/04/2022 Product Code DSQ Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement request A Change To The Post-conditioning Aeration Process Following Ethylene Oxide Sterilization And The Addition Of Another Aeration Chamber |
| 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 |