PMA P880086S196

Device
ACCENT PACERS AND ANTHEM RF CRT-P DEVICES
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S196
Product code
NVZ
Decision date
2011-01-14
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
USE OF ALTERNATE UV CURE ADHESIVE FROM AN ALTERNATE SUPPLIER.

Current openFDA PMA Record#

Device
ACCENT PACERS AND ANTHEM RF CRT-P DEVICES
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S196
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2011-01-14
Decision code
OK30
Date received
2010-12-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF ALTERNATE UV CURE ADHESIVE FROM AN ALTERNATE SUPPLIER.