PMA P920047S135

Device: IntellaNav ST Ablation Catheter
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S135
Product code: LPB
Decision date: 2025-03-20
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
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 ST Ablation Catheter
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S135
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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