PMA P000018S029
- Device
- NOVOSTE BETA-CATH 3.5F SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S029
- Product code
- MOU
- Decision date
- 2003-07-18
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR THE BETA-RAIL 3.5F XL DELIVERY CATHETER AND ENHANCED BETA-RAIL 3.5F DELIVERY CATHETER.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH 3.5F SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S029
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-07-18
- Decision code
- APPR
- Date received
- 2003-01-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE BETA-RAIL 3.5F XL DELIVERY CATHETER AND ENHANCED BETA-RAIL 3.5F DELIVERY CATHETER.