PMA P960013S024

Device
TENDRIL 1688T/TC LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S024
Product code
NVZ
Decision date
2006-12-11
Generic name
Pulse generator, permanent, implantable
Approval order statement
REVISION TO THE WELD PROCESS OF THE INNER COIL TO THE SHAFT COUPLING/SPRING ASSEMBLY.

Current openFDA PMA Record#

Device
TENDRIL 1688T/TC LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S024
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-12-11
Decision code
OK30
Date received
2006-11-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REVISION TO THE WELD PROCESS OF THE INNER COIL TO THE SHAFT COUPLING/SPRING ASSEMBLY.