PMA P960013S041

Device
TENDRIL ST LEAD
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S041
Product code
NVZ
Decision date
2008-12-31
Generic name
Pulse generator, permanent, implantable
Approval order statement
CHANGE TO ELIMINATE THE PLASMA PRIMING PROCESS.

Current openFDA PMA Record#

Device
TENDRIL ST LEAD
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S041
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2008-12-31
Decision code
OK30
Date received
2008-12-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO ELIMINATE THE PLASMA PRIMING PROCESS.