QUIK-PAK Electrodes

FDA Premarket Approval P160012 S006

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

DeviceQUIK-PAK Electrodes
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control. Inc.11811 Willows Rd. Neredmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-05-16
Decision Date2022-07-20
PMAP160012
SupplementS006
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressPhysio-Control. Inc.
11811 Willows Rd. Ne
redmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For A Temporary Shelf-life Extension Up To 9 Months Beyond The Expiration Date For Units Already Distributed In The Field That Meet The Required Storage Conditions.

Supplemental Filings

Supplement NumberDateSupplement Type
P160012Original Filing
S006 2022-05-16 Real-time Process
S005
S004 2020-04-16 30-day Notice
S003
S002
S001

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