PMA P000018S023
- Device
- NOVOSTE(TM) BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S023
- Product code
- MOU
- Decision date
- 2002-07-31
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO IMPLEMENT A NEW PROCESS OF APPLYING THE O-RINGS TO THE PROPRIETARY CONNECTOR USING AN O-RING INSTALLATION TOOL.
Current openFDA PMA Record#
- Device
- NOVOSTE(TM) BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S023
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2002-07-31
- Decision code
- OK30
- Date received
- 2002-07-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO IMPLEMENT A NEW PROCESS OF APPLYING THE O-RINGS TO THE PROPRIETARY CONNECTOR USING AN O-RING INSTALLATION TOOL.