PMA P910023S185

Device
CADENCE ICD SYSTEM
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S185
Product code
NVZ
Decision date
2008-08-19
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABELING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER.)

Current openFDA PMA Record#

Device
CADENCE ICD SYSTEM
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S185
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2008-08-19
Decision code
APPR
Date received
2008-08-11
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE QUICKSTART GUIDE (LABELING FOR THE MERLIN@HOME DM EX1150 TRANSMITTER.)