PMA P950001S021

Device
SELUTE
Applicant
Boston Scientific
PMA number
P950001
Supplement
S021
Product code
NVY
Decision date
2010-01-15
Generic name
Permanent defibrillator electrodes
Approval order statement
ADDITION OF STERILIZATION HOOP RACKS.

Current openFDA PMA Record#

Device
SELUTE
Applicant
Boston Scientific
PMA number
P950001
Supplement
S021
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2010-01-15
Decision code
OK30
Date received
2009-12-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF STERILIZATION HOOP RACKS.