PMA P990071S063

Device: SMARTABLATE™ Irrigation Tubing Set
Applicant: Biosense Webster, Inc.
PMA number: P990071
Supplement: S063
Product code: LPB
Decision date: 2025-02-11
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: the implementation of an ethylene oxide (EO) sterilization cycle as an alternate sterilization method at a new sterilization site (Sterigenics Santa Teresa, NM) for the SMARTABLATE™ Irrigation Tubing Set

Current openFDA PMA Record#

Device: SMARTABLATE™ Irrigation Tubing Set
Applicant: Biosense Webster, Inc.
PMA number: P990071
Supplement: S063
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2025-02-11
Decision code: APPR
Date received: 2024-11-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: the implementation of an ethylene oxide (EO) sterilization cycle as an alternate sterilization method at a new sterilization site (Sterigenics Santa Teresa, NM) for the SMARTABLATE™ Irrigation Tubing Set