PMA P000018S031
- Device
- NOVOSTE BETA-CATH 3.5 SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S031
- Product code
- MOU
- Decision date
- 2003-03-17
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE BETA-RAIL 3.5F DELIVERY CATHETER.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH 3.5 SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S031
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-03-17
- Decision code
- APPR
- Date received
- 2003-02-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING PROCESS OF THE BETA-RAIL 3.5F DELIVERY CATHETER.