PMA P000018S030
- Device
- NOVOSTE TM BETA-CATH TM SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S030
- Product code
- MOU
- Decision date
- 2003-02-26
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- ALTERNATE METHOD OF MANUFACTURE FOR THE LEAK TESTING AND DRYING OPERATION OF THE BETA-RAIL 3.5F DELIVERY CATHETER.
Current openFDA PMA Record#
- Device
- NOVOSTE TM BETA-CATH TM SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S030
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-02-26
- Decision code
- OK30
- Date received
- 2003-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE METHOD OF MANUFACTURE FOR THE LEAK TESTING AND DRYING OPERATION OF THE BETA-RAIL 3.5F DELIVERY CATHETER.