LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator

FDA Premarket Approval P160012 S004

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.

Pre-market Approval Supplement Details

A manufacturing change of the outer enclosure during assembly of lifepak cr plus and lifepak express defibrillators

DeviceLIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control. Inc.
Date Received2020-04-16
Decision Date2020-05-13
PMAP160012
SupplementS004
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Physio-Control. Inc. 11811 Willows Rd. Ne redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P160012Original Filing
S004 2020-04-16 30-day Notice
S003
S002
S001

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.