PMA P000018S016
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S016
- Product code
- MOU
- Decision date
- 2002-01-30
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE 30 MM AND 40 MM BET SYSTEMS. THE REVISED POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATIONS, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.
Current openFDA PMA Record#
- Device
- NOVOSTE BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S016
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2002-01-30
- Decision code
- APPR
- Date received
- 2001-08-07
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE 30 MM AND 40 MM BET SYSTEMS. THE REVISED POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATIONS, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE.