FDA.reportPublic FDA data

PMA P960013S112

Device
OptiSense Steroid Eluting Cardiac Lead
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S112
Product code
NVN
Decision date
2020-06-17
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for OptiSense leads MCRD component manufacturing.

Current openFDA PMA Record#

Device
OptiSense Steroid Eluting Cardiac Lead
Applicant
ABBOTT MEDICAL
PMA number
P960013
Supplement
S112
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2020-06-17
Decision code
OK30
Date received
2020-05-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for OptiSense leads MCRD component manufacturing.