PMA P020025S144

Device: IntellaNav MiFi XP Ablation Catheter
Applicant: Boston Scientific
PMA number: P020025
Supplement: S144
Product code: OAD
Decision date: 2025-03-20
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: the transfer of manufacturing and packaging assembly operations for the IntellaNav MiFi XP and IntellaNav ST ablation catheters to the Coyol, Costa Rica facility

Current openFDA PMA Record#

Device: IntellaNav MiFi XP Ablation Catheter
Applicant: Boston Scientific
PMA number: P020025
Supplement: S144
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2025-03-20
Decision code: OK30
Date received: 2025-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the transfer of manufacturing and packaging assembly operations for the IntellaNav MiFi XP and IntellaNav ST ablation catheters to the Coyol, Costa Rica facility