PMA P960013S021

Device
TENDRIL FAMILY OF LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S021
Product code
NVZ
Decision date
2006-07-19
Generic name
Pulse generator, permanent, implantable
Approval order statement
ALTERNATE AUTOMATED TEST PROCESS DURING THE INSPECTION OF TENDRIL FAMILY OF LEADS.

Current openFDA PMA Record#

Device
TENDRIL FAMILY OF LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S021
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-07-19
Decision code
OK30
Date received
2006-07-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE AUTOMATED TEST PROCESS DURING THE INSPECTION OF TENDRIL FAMILY OF LEADS.