PMA P920015S289

Device
Transvene CS/SVC Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S289
Product code
NVY
Decision date
2024-07-01
Classification
Cardiovascular
Generic name
Permanent defibrillator electrodes
Approval order statement
an alternate manufacturing method at a supplier

Current openFDA PMA Record#

Device
Transvene CS/SVC Lead
Applicant
Medtronic, Inc.
PMA number
P920015
Supplement
S289
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2024-07-01
Decision code
OK30
Date received
2024-06-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an alternate manufacturing method at a supplier