PMA P950001S025

Device
SELUTE LEAD FAMILY
Applicant
Boston Scientific
PMA number
P950001
Supplement
S025
Product code
NVY
Decision date
2012-12-05
Generic name
Permanent defibrillator electrodes
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.

Current openFDA PMA Record#

Device
SELUTE LEAD FAMILY
Applicant
Boston Scientific
PMA number
P950001
Supplement
S025
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2012-12-05
Decision code
OK30
Date received
2012-11-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.