PMA P950001S017

Device
SELUTE
Applicant
Boston Scientific
PMA number
P950001
Supplement
S017
Product code
NVY
Decision date
2006-05-12
Generic name
Permanent defibrillator electrodes
Approval order statement
CHANGES TO THE BIOBURDEN SAMPLING PLAN.

Current openFDA PMA Record#

Device
SELUTE
Applicant
Boston Scientific
PMA number
P950001
Supplement
S017
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2006-05-12
Decision code
OK30
Date received
2006-04-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO THE BIOBURDEN SAMPLING PLAN.