NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM
FDA premarket approval P000018/S018 · decided 2002-03-25
Approval details
- PMA number
- P000018
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE 60 MM BETA-CATH 5 FR SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-08-31
- Decision date
- 2002-03-25
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM. THE NOVOSTE BETA-CATH 60 MM 5 FR SYSTEM IS INTENDED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS WITH INJURY AREAS UP TO 40 MM IN A REFERENCE VESSLE DIAMETER RANGING FROM 2.7 MM TO 4.0 MM.
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