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 | HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507 |
| Generic Name | Over-the-counter Automated External Defibrillator |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC.22100 Bothell -everett Hwybothell, WA 98021 PMA NumberP160029 Supplement NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-07-27 |
| PMA | P160029 |
| Supplement | S017 |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell -everett Hwy bothell, WA 98021 PMA NumberP160029 Supplement NumberS017 Date Received07/05/2022 Decision Date07/27/2022 Product Codes NSA MKJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement request Approval To Replace The Current Water Spray System On The Hydrogel Heat Cure Line With A New Water Spray System In Order To Reduce The Variation In The Final Gel Water Content |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160029 | Original Filing | |
| S017 | 2022-07-05 | 30-day Notice |
| S016 | 2022-05-11 | 30-day Notice |
| S015 | 2022-02-22 | 30-day Notice |
| S014 | ||
| S013 | 2021-07-30 | 30-day Notice |
| S012 | 2021-05-21 | 30-day Notice |
| S011 | 2021-03-22 | 30-day Notice |
| S010 | 2021-02-23 | 30-day Notice |
| S009 | 2021-01-21 | 30-day Notice |
| S008 | ||
| S007 | 2020-11-16 | 30-day Notice |
| S006 | 2020-07-31 | 30-day Notice |
| S005 | 2020-07-06 | 30-day Notice |
| S004 | 2020-06-19 | 30-day Notice |
| S003 | ||
| S002 | 2019-11-18 | 30-day Notice |
| S001 |