PMA P950024S065

Device
CAPSURE EPICARDIAL PACING LEAD
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S065
Product code
NVY
Decision date
2015-10-02
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.

Current openFDA PMA Record#

Device
CAPSURE EPICARDIAL PACING LEAD
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S065
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2015-10-02
Decision code
OK30
Date received
2015-09-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF NEW SERIAL NUMBER PRINTING SOFTWARE WITHIN THE EXISTING TRACEABILITY SYSTEM.