PMA P000018S044
- Device
- BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S044
- Product code
- MOU
- Decision date
- 2011-02-23
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- BETA-CATH SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S044
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2011-02-23
- Decision code
- APPR
- Date received
- 2010-09-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.