PMA P920015S298

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S298
Product code
NVY
Decision date
2025-04-01
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
the modification of the reserve sample selection process for combination product leads

Current openFDA PMA Record#

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S298
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2025-04-01
Decision code
OK30
Date received
2025-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the modification of the reserve sample selection process for combination product leads