PMA P960004S084

Device
Fineline ll Lead Family
Applicant
Boston Scientific
PMA number
P960004
Supplement
S084
Product code
NVN
Decision date
2018-05-16
Classification
Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Add alternate drug identifying equipment.

Current openFDA PMA Record#

Device
Fineline ll Lead Family
Applicant
Boston Scientific
PMA number
P960004
Supplement
S084
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2018-05-16
Decision code
OK30
Date received
2018-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add alternate drug identifying equipment.