PMA P000018S047
- Device
- BETA-CATH (TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S047
- Product code
- MOU
- Decision date
- 2016-07-26
- Classification
- Intravascular Radiation Delivery System
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- Use of a new supplier and a change to the Bacterial Endotoxin Test sampling plan.
Current openFDA PMA Record#
- Device
- BETA-CATH (TM) SYSTEM
- Applicant
- Best Vascular, Inc.
- PMA number
- P000018
- Supplement
- S047
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2016-07-26
- Decision code
- OK30
- Date received
- 2016-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new supplier and a change to the Bacterial Endotoxin Test sampling plan.