PMA P910073S187

Device: ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads
Applicant: Boston Scientific
PMA number: P910073
Supplement: S187
Product code: LWS
Decision date: 2026-03-06
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.

Current openFDA PMA Record#

Device: ENDOTAK RELIANCE™ / RELIANCE 4-FRONT™ pace/sense defibrillation leads
Applicant: Boston Scientific
PMA number: P910073
Supplement: S187
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-03-06
Decision code: APPR
Date received: 2026-01-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.