PMA P000018S041
- Device
- NOVOSTE BETA - CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S041
- Product code
- MOU
- Decision date
- 2004-10-04
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORCROSS, GEORGIA, TO PROCESS RADIATION SOURCE TRAINS FOR THE BETA-CATH SYSTEM.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA - CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S041
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2004-10-04
- Decision code
- APPR
- Date received
- 2004-06-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORCROSS, GEORGIA, TO PROCESS RADIATION SOURCE TRAINS FOR THE BETA-CATH SYSTEM.