PMA P920015S271

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S271
Product code
NVY
Decision date
2022-09-15
Generic name
Permanent defibrillator electrodes
Approval order statement
Minor updates for manufacturing and inspection processes for the Monolithic Controlled Release Devices.

Current openFDA PMA Record#

Device
Sprint Quattro Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S271
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2022-09-15
Decision code
OK30
Date received
2022-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor updates for manufacturing and inspection processes for the Monolithic Controlled Release Devices.