PMA P000018S026

Device: NOVOSTE BETA-CATH 3.5F SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S026
Product code: MOU
Decision date: 2002-11-13
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS.

Current openFDA PMA Record#

Device: NOVOSTE BETA-CATH 3.5F SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S026
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2002-11-13
Decision code: APPR
Date received: 2002-10-18
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS.