PMA P960004S116

Device: ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480
Applicant: Boston Scientific
PMA number: P960004
Supplement: S116
Product code: NVN
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility

Current openFDA PMA Record#

Device: ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480
Applicant: Boston Scientific
PMA number: P960004
Supplement: S116
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility