|
Device | HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) |
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 | S024 |
Date Received | 01/23/2024 |
Decision Date | 02/21/2024 |
Product Codes |
MKJ NSA |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a battery manufacturing site located at Panasonic Energy Mexico, S.A. de C.V., Escobedo N.L., Mexico |