PMA P000018S027
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S027
- Product code
- MOU
- Decision date
- 2003-10-23
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL TO CHANGE AN ELECTRONIC DATA MANAGEMENT SYSTEM, REFERRED TO AS THE BETACAL SYSTEM.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S027
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-10-23
- Decision code
- APPR
- Date received
- 2002-10-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE AN ELECTRONIC DATA MANAGEMENT SYSTEM, REFERRED TO AS THE BETACAL SYSTEM.