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PMA P960004S091

Device
FINELINE II Steroid-Eluting Pacing Leads
Applicant
Boston Scientific
PMA number
P960004
Supplement
S091
Product code
NVN
Decision date
2020-09-25
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Updates to manufacturing work instructions and tool inspection for the cathode coil threading process for the FINELINE II Steroid-Eluting pacing leads.

Current openFDA PMA Record#

Device
FINELINE II Steroid-Eluting Pacing Leads
Applicant
Boston Scientific
PMA number
P960004
Supplement
S091
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2020-09-25
Decision code
OK30
Date received
2020-09-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to manufacturing work instructions and tool inspection for the cathode coil threading process for the FINELINE II Steroid-Eluting pacing leads.