|
Device | LIFEPAK Automated External Defibrillators (AEDs) |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | Physio-Control. Inc. 11811 Willows Road NE Redmond, WA 98052 |
PMA Number | P160026 |
Supplement Number | S017 |
Date Received | 05/04/2020 |
Decision Date | 07/29/2020 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design changes associated with the Auxiliary Power Harness component of the LIFEPAK 15 monitor/defibrillator due to obsolescence of the potting material. |