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.
A manufacturing change of the outer enclosure during assembly of lifepak cr plus and lifepak express defibrillators
|Device||LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator|
|Generic Name||Automated External Defibrillators (non-wearable)|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Physio-Control. Inc. 11811 Willows Rd. Ne redmond, WA 98052|
|Supplement Number||Date||Supplement Type|