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 | Avalus |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Medtronic Inc.1851 E. Deere Avenuesanta Ana, CA 92705 PMA NumberP170006 Supplement NumberS021 Date Received07/20/2022 Decision Date08/03/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-20 |
| Decision Date | 2022-08-03 |
| PMA | P170006 |
| Supplement | S021 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Inc. 1851 E. Deere Avenue santa Ana, CA 92705 PMA NumberP170006 Supplement NumberS021 Date Received07/20/2022 Decision Date08/03/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement re-validation Of An Existing Cleanroom |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170006 | Original Filing | |
| S021 | 2022-07-20 | 30-day Notice |
| S020 | 2022-02-28 | 30-day Notice |
| S019 | 2020-11-25 | 30-day Notice |
| S018 | 2020-10-02 | Real-time Process |
| S017 | 2020-08-03 | 30-day Notice |
| S016 | 2019-09-26 | Real-time Process |
| S015 | 2019-06-20 | 30-day Notice |
| S014 | 2019-05-31 | 30-day Notice |
| S013 | ||
| S012 | 2019-05-03 | 30-day Notice |
| S011 | 2019-04-18 | 30-day Notice |
| S010 | 2019-01-29 | 30-day Notice |
| S009 | 2019-01-24 | 30-day Notice |
| S008 | 2018-11-21 | 30-day Notice |
| S007 | ||
| S006 | 2018-07-27 | 30-day Notice |
| S005 | 2017-11-22 | 30-day Notice |
| S004 | 2017-10-23 | 30-day Notice |
| S003 | 2017-10-18 | 30-day Notice |
| S002 | ||
| S001 | 2017-09-11 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169983212 | P170006 | 000 |
| 00643169983205 | P170006 | 000 |
| 00643169983199 | P170006 | 000 |
| 00643169983182 | P170006 | 000 |
| 00643169983175 | P170006 | 000 |
| 00643169983229 | P170006 | 024 |