PMA P960013S075

Device
TENDRILL STS MODEL 2088TC LEAD
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S075
Product code
NVN
Decision date
2013-05-29
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
ADD AN ALTERNATE SUPPLIER OF A LEAD TIP COMPONENT.

Current openFDA PMA Record#

Device
TENDRILL STS MODEL 2088TC LEAD
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S075
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2013-05-29
Decision code
OK30
Date received
2013-05-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADD AN ALTERNATE SUPPLIER OF A LEAD TIP COMPONENT.