Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: 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; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P020025
• Supplement Number: S147
• Date Received: 09/19/2025
• Decision Date: 10/17/2025
• Product Code: OAD
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
the addition of a new soldering machine at a supplier