PMA P000018S025
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S025
- Product code
- MOU
- Decision date
- 2003-01-06
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN).
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S025
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-01-06
- Decision code
- APPR
- Date received
- 2002-10-15
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN).