|
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 | S018 |
Date Received | 10/02/2023 |
Decision Date | 10/11/2023 |
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 implementation of a change in the final wash process step performed at the Tier 1 Supplier |