PMA P000018S040
- Device
- NOVOSTE BETA-CATH 3.5F SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S040
- Product code
- MOU
- Decision date
- 2004-06-10
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR THE BETA-RAIL 3.5F DELIVERY CATHETER WITH DISTAL IMPROVEMENTS, AND A CHANGE IN THE PROCEDURE ACCESSORY PACK.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH 3.5F SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S040
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2004-06-10
- Decision code
- APPR
- Date received
- 2003-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE BETA-RAIL 3.5F DELIVERY CATHETER WITH DISTAL IMPROVEMENTS, AND A CHANGE IN THE PROCEDURE ACCESSORY PACK.