ASSURE Wearable Cardioverter Defibrillator (WCD) System

FDA Premarket Approval P200037 S005

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

DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic NameWearable Automated External Defibrillator
ApplicantKestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS005 Date Received09/28/2022 Decision Date10/27/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-28
Decision Date2022-10-27
PMAP200037
SupplementS005
Product CodeMVK 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressKestra Medical Technologies, Inc.
3933 Lake Washington Boulevard, N.e.
suite 200
kirkland, WA 98033 PMA NumberP200037 Supplement NumberS005 Date Received09/28/2022 Decision Date10/27/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Alternate Diode And N-Channel MOSFET Component To Be Used On The Therapy And H-Bridge PCBA

Supplemental Filings

Supplement NumberDateSupplement Type
P200037Original Filing
S005 2022-09-28 30-day Notice
S004 2022-06-02 Normal 180 Day Track
S003 2021-11-17 30-day Notice
S002
S001 2021-09-15 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00840241600207 P200037 000
00840241600085 P200037 000
00840241600078 P200037 000
00840241600061 P200037 000
00840241600054 P200037 000
00840241600047 P200037 000
00840241600030 P200037 000
00840241600023 P200037 000
00840241600016 P200037 000
00840241600092 P200037 000
00840241600108 P200037 000
00840241600115 P200037 000
00840241600191 P200037 000
00840241600184 P200037 000
00840241600177 P200037 000
00840241600160 P200037 000
00840241600153 P200037 000
00840241600146 P200037 000
00840241600139 P200037 000
00840241600122 P200037 000
00840241600009 P200037 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.