Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation
FDA premarket approval P150005/S088 · decided 2025-09-02
Approval details
- PMA number
- P150005
- Supplement
- S088
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific Corp
- Date received
- 2025-07-03
- Decision date
- 2025-09-02
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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)
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |