PMA P000018S013
- Device
- BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S013
- Product code
- MOU
- Decision date
- 2001-10-18
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
Current openFDA PMA Record#
- Device
- BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S013
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2001-10-18
- Decision code
- APPR
- Date received
- 2001-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS.