PMA P150005S091

Device: RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™)
Applicant: Boston Scientific Corp
PMA number: P150005
Supplement: S091
Product code: OAD
Decision date: 2025-10-17
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: the addition of a new soldering machine at a supplier

Current openFDA PMA Record#

Device: RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010); Rhythmia HDx™ Ablation Connection Box (Maestro™)
Applicant: Boston Scientific Corp
PMA number: P150005
Supplement: S091
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-10-17
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new soldering machine at a supplier