BETA-CATH(TM) SYSTEM
FDA premarket approval P000018/S013 · decided 2001-10-18
Approval details
- PMA number
- P000018
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BETA-CATH(TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-04-24
- Decision date
- 2001-10-18
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR MODIFICATION TO THE DESIGN OF THE TRANSFER DEVICE, THE ADDITION OF A TWIN TRANSPORT CASE TO THE TRANSPORT SYSTEM, A MODIFICATION TO THE SOURCE COLLECTION CONTAINER, AND A MODIFICATION TO THE FLUID COLLECTION BAG,K OF THE 30 MM AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
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