PMA P960013S052

Device
TENDRIL LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S052
Product code
NVN
Decision date
2010-01-20
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
APPROVAL FOR A NEW LEAD COMPONENT SUPPLIER.

Current openFDA PMA Record#

Device
TENDRIL LEADS
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S052
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2010-01-20
Decision code
APPR
Date received
2009-08-31
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A NEW LEAD COMPONENT SUPPLIER.