PMA P910073S191

Device: Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266
Applicant: Boston Scientific
PMA number: P910073
Supplement: S191
Product code: LWS
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
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: Endotak Reliance Leads (0128, 0137, 0138, 0147, 0148, 0157, 0158); Endotak Reliance 4-Site Leads (0262, 0263, 0265, 0266
Applicant: Boston Scientific
PMA number: P910073
Supplement: S191
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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