PMA P000018S008
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S008
- Product code
- MOU
- Decision date
- 2001-10-26
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE STERILE BAG AND FLUID COLLECTION BAG PROVIDED IN THE PROCEDURE ACCESSORY PACK.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S008
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2001-10-26
- Decision code
- APPR
- Date received
- 2001-02-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE STERILE BAG AND FLUID COLLECTION BAG PROVIDED IN THE PROCEDURE ACCESSORY PACK.