PMA P150005S088

Device: Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation
Applicant: Boston Scientific Corp
PMA number: P150005
Supplement: S088
Product code: OAD
Decision date: 2025-09-02
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: brand name changes for Ablation Connection Boxes to reflect a new electrophysiology mapping system brand name (RHYTHMIA HDx Mapping System to OPAL HDx Mapping System)

Current openFDA PMA Record#

Device: Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation
Applicant: Boston Scientific Corp
PMA number: P150005
Supplement: S088
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-09-02
Decision code: APPR
Date received: 2025-07-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: brand name changes for Ablation Connection Boxes to reflect a new electrophysiology mapping system brand name (RHYTHMIA HDx Mapping System to OPAL HDx Mapping System)