PMA P000018S012
- Device
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S012
- Product code
- MOU
- Decision date
- 2001-08-01
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR AN ALTERNATE METHOD OF RECEIPT AND ASSEMBLING OF SOURCE TRAINS.
Current openFDA PMA Record#
- Device
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S012
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2001-08-01
- Decision code
- APPR
- Date received
- 2001-03-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE METHOD OF RECEIPT AND ASSEMBLING OF SOURCE TRAINS.