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.
Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160015.
| Device | AED 3 Defibrillator with Uni-Padz |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION |
| Date Received | 2020-03-27 |
| Decision Date | 2020-06-05 |
| PMA | P160015 |
| Supplement | S004 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160015 | Original Filing | |
| S014 | 2022-05-20 | 30-day Notice |
| S013 | 2022-02-23 | 30-day Notice |
| S012 | 2021-08-06 | 30-day Notice |
| S011 | 2021-02-24 | 30-day Notice |
| S010 | 2021-02-16 | 30-day Notice |
| S009 | 2020-12-18 | 30-day Notice |
| S008 | 2020-12-16 | 30-day Notice |
| S007 | 2020-12-15 | 30-day Notice |
| S006 | 2020-09-28 | 30-day Notice |
| S005 | ||
| S004 | 2020-03-27 | Normal 180 Day Track No User Fee |
| S003 | 2020-01-03 | 30-day Notice |
| S002 | 2018-08-23 | 135 Review Track For 30-day Notice |
| S001 |