RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro)
FDA premarket approval P020025/S147 · decided 2025-10-17
Approval details
- PMA number
- P020025
- Supplement
- S147
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro)
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2025-09-19
- Decision date
- 2025-10-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- the addition of a new soldering machine at a supplier
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