Powerheart® G5 AED

FDA Premarket Approval P160033 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

New manufacturing equipment and alternate material for printed circuit boards

DevicePowerheart® G5 AED
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantZOLL Medical Corporation
Date Received2021-01-08
Decision Date2021-02-02
PMAP160033
SupplementS005
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ZOLL Medical Corporation 269 Mill Road chelmsford, MA 01824

Supplemental Filings

Supplement NumberDateSupplement Type
P160033Original Filing
S005 2021-01-08 30-day Notice
S004 2019-08-01 30-day Notice
S003
S002 2019-04-29 Normal 180 Day Track
S001 2018-12-17 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00812394023288 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023189 P160033 000
00812394023172 P160033 000
00812394023349 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023295 P160033 000
00812394023325 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023271 P160033 000
00812394023219 P160033 000
00812394023202 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023332 P160033 000
00812394023271 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023301 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023349 P160033 000
00812394023332 P160033 000
00812394023325 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023301 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023202 P160033 000
00812394023271 P160033 000
00812394023301 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023349 P160033 000
00812394023332 P160033 000
00812394023325 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023325 P160033 000
00812394023332 P160033 000
00812394023349 P160033 000
00812394023301 P160033 000
00812394023172 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023219 P160033 000
00812394023271 P160033 000
00812394023288 P160033 000
00812394023295 P160033 000
00812394023318 P160033 000
00812394023219 P160033 000
00812394023349 P160033 000
00812394023172 P160033 000
00812394023318 P160033 000
00812394023219 P160033 000
00812394023349 P160033 000
00812394023332 P160033 000
00812394023325 P160033 000
00812394023318 P160033 000
00812394023295 P160033 000
00812394023288 P160033 000
00812394023271 P160033 000
00812394023219 P160033 000
00812394023189 P160033 000
00812394023202 P160033 000
00812394023158 P160033 004
00812394023141 P160033 004
00812394023134 P160033 004
00812394023127 P160033 004
00812394023110 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023103 P160033 004
00812394023097 P160033 004
00812394022779 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023110 P160033 004
00812394023103 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023165 P160033 004
00812394023127 P160033 004
00812394022243 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023103 P160033 004
00812394023097 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394023134 P160033 004
00812394023127 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023165 P160033 004
00812394023158 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023158 P160033 004
00812394023165 P160033 004
00812394022243 P160033 004
00812394022779 P160033 004
00812394023097 P160033 004
00812394023103 P160033 004
00812394023110 P160033 004
00812394023127 P160033 004
00812394023134 P160033 004
00812394023141 P160033 004
00812394023110 P160033 004

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.