PMA P000018S017
- Device
- NOVOSTE (TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S017
- Product code
- MOU
- Decision date
- 2001-09-26
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- ALTERNATE METHOD OF MANUFACTURE FOR THE DRYING OPERATION OF THE BETA-CATH(TM) DELIVERY CATHETER.
Current openFDA PMA Record#
- Device
- NOVOSTE (TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S017
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2001-09-26
- Decision code
- OK30
- Date received
- 2001-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE METHOD OF MANUFACTURE FOR THE DRYING OPERATION OF THE BETA-CATH(TM) DELIVERY CATHETER.