PMA P910073

Device: ENDOTAK LEAD SYSTEM
Applicant: Boston Scientific
PMA number: P910073
Supplement: S171
Product code: LWS
Decision date: 2026-09-17
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval for supplemental labeling for the ENDOTAK RELIANCE ePTFE family of defibrillator leads to align with a July 2025 Product Advisory.

Current openFDA PMA Record#

Device: ENDOTAK LEAD SYSTEM
Applicant: Boston Scientific
PMA number: P910073
Supplement: S193
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-09-17
Decision code: APPR
Date received: 2026-08-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for supplemental labeling for the ENDOTAK RELIANCE ePTFE family of defibrillator leads to align with a July 2025 Product Advisory.