Note: 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. |
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Device | HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P |
Generic Name | Over-the-counter automated external defibrillator |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. 22100 BOTHELL -EVERETT HWY BOTHELL, WA 98021 |
PMA Number | P160029 |
Supplement Number | S022 |
Date Received | 01/02/2024 |
Decision Date | 01/23/2024 |
Product Codes |
MKJ NSA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement qualification of two new impedance test stations that add a supplemental inspection step to the manufacturing process |
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