FDA.reportPublic FDA data

PMA P960013S079

Device
TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S079
Product code
NVY
Decision date
2016-02-17
Classification
Permanent Defibrillator Electrodes
Generic name
Permanent defibrillator electrodes
Approval order statement
Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.

Current openFDA PMA Record#

Device
TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S079
Product code
NVY
Generic name
Permanent defibrillator electrodes
Decision date
2016-02-17
Decision code
OK30
Date received
2016-01-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the First Article Inspection procedure, an addition of pull testing of extruded tubing, a change in location for an extrusion process, and a change to the curing parameters of a polymer.