|
Device | LIFEPAK® CR2 defibrillator |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | Physio-Control, Inc 11811 Willows Road NE Redmond, WA 98052 |
PMA Number | P170018 |
Supplement Number | S019 |
Date Received | 04/04/2024 |
Decision Date | 04/23/2024 |
Product Code |
MKJ |
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 the addition of a new manufacturing site location for a capacitor component |