PMA P920015S263

Device
HV Splitter/Adaptor kit, Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S263
Product code
NVY
Decision date
2021-12-13
Generic name
Permanent defibrillator electrodes
Approval order statement
Add a visual inspection for selected components at Medtronic Rice Creek (Fridley, MN).

Current openFDA PMA Record#

Device
HV Splitter/Adaptor kit, Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S263
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2021-12-13
Decision code
OK30
Date received
2021-11-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a visual inspection for selected components at Medtronic Rice Creek (Fridley, MN).