PMA P910023S235

Device
CADENCE FAMILY OF ICDS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S235
Product code
NVZ
Decision date
2010-06-18
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
ALTERNATE METHOD OF BIOBURDEN TESTING.

Current openFDA PMA Record#

Device
CADENCE FAMILY OF ICDS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S235
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2010-06-18
Decision code
OK30
Date received
2010-05-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE METHOD OF BIOBURDEN TESTING.