|
Device | ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD Chelmsford, MA 01824 |
PMA Number | P160015 |
Supplement Number | S008 |
Date Received | 12/16/2020 |
Decision Date | 12/30/2020 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement new tin-to-wire machines used in the manufacture of electrode assemblies |