PMA P920015S291

Device
Tunneling Tool
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S291
Product code
NVY
Decision date
2024-08-15
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
modifying the Medtronic Tunneling Tool sterilization load configuration

Current openFDA PMA Record#

Device
Tunneling Tool
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S291
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2024-08-15
Decision code
OK30
Date received
2024-07-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
modifying the Medtronic Tunneling Tool sterilization load configuration