PMA P020025S145

Device: RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)
Applicant: Boston Scientific
PMA number: P020025
Supplement: S145
Product code: OAD
Decision date: 2025-03-31
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: the addition of a new injection molding machine at a supplier

Current openFDA PMA Record#

Device: RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)
Applicant: Boston Scientific
PMA number: P020025
Supplement: S145
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-03-31
Decision code: OK30
Date received: 2025-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new injection molding machine at a supplier