NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S035 · decided 2004-02-17
Approval details
- PMA number
- P000018
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2003-08-21
- Decision date
- 2004-02-17
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ALPHA-SERIES TRANSFER DEVICES (ALPHA IV, REV. 2, ALPHA V, AND ALPHA VI), AND MODIFICATIONS TO THE LABELING FOR THE BETA-CATH 5F AND BETA-CATH 3.5F SYSTEMS.
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