PMA P920015S264

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S264
Product code
NVY
Decision date
2022-01-28
Generic name
Permanent defibrillator electrodes
Approval order statement
Minor modifications to combination product processes at Medtronic Rice Creek.

Current openFDA PMA Record#

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S264
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2022-01-28
Decision code
OK30
Date received
2022-01-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor modifications to combination product processes at Medtronic Rice Creek.