FDA.reportPublic FDA data

PMA P960013S113

Device
Tendril SDX, OptiSense, Tendril STS, Tendril ST
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S113
Product code
NVN
Decision date
2020-06-18
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.

Current openFDA PMA Record#

Device
Tendril SDX, OptiSense, Tendril STS, Tendril ST
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S113
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.