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 | ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) |
| Generic Name | Wearable Automated External Defibrillator |
| Applicant | Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS006 Date Received12/12/2022 Decision Date01/10/2023 Product Code MVK Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-12 |
| Decision Date | 2023-01-10 |
| PMA | P200037 |
| Supplement | S006 |
| Product Code | MVK |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Kestra Medical Technologies, Inc. 3933 Lake Washington Boulevard, N.e. suite 200 kirkland, WA 98033 PMA NumberP200037 Supplement NumberS006 Date Received12/12/2022 Decision Date01/10/2023 Product Code MVK Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement utilizing A New Washer For The Printed Circuit Board Assembly Of Critical Components |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200037 | Original Filing | |
| S006 | 2022-12-12 | 30-day Notice |
| S005 | 2022-09-28 | 30-day Notice |
| S004 | 2022-06-02 | Normal 180 Day Track |
| S003 | 2021-11-17 | 30-day Notice |
| S002 | ||
| S001 | 2021-09-15 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00840241600207 | P200037 | 000 |
| 00840241600085 | P200037 | 000 |
| 00840241600078 | P200037 | 000 |
| 00840241600061 | P200037 | 000 |
| 00840241600054 | P200037 | 000 |
| 00840241600047 | P200037 | 000 |
| 00840241600030 | P200037 | 000 |
| 00840241600023 | P200037 | 000 |
| 00840241600016 | P200037 | 000 |
| 00840241600009 | P200037 | 000 |
| 00840241600092 | P200037 | 000 |
| 00840241600108 | P200037 | 000 |
| 00840241600191 | P200037 | 000 |
| 00840241600184 | P200037 | 000 |
| 00840241600177 | P200037 | 000 |
| 00840241600160 | P200037 | 000 |
| 00840241600153 | P200037 | 000 |
| 00840241600146 | P200037 | 000 |
| 00840241600139 | P200037 | 000 |
| 00840241600122 | P200037 | 000 |
| 00840241600115 | P200037 | 000 |
| 00840241600238 | P200037 | 000 |