PMA P920015S301

Device
print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S301
Product code
NVY
Decision date
2025-07-16
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
a new vapor degreasing solvent

Current openFDA PMA Record#

Device
print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S301
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2025-07-16
Decision code
OK30
Date received
2025-06-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new vapor degreasing solvent