PMA P000018S011
- Device
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S011
- Product code
- MOU
- Decision date
- 2001-08-22
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE PROXIMAL MARKER OF THE SOURCE TRAIN.
Current openFDA PMA Record#
- Device
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S011
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2001-08-22
- Decision code
- APPR
- Date received
- 2001-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE PROXIMAL MARKER OF THE SOURCE TRAIN.