NOVOSTE 40 MM BETA-CATH SYSTEM
FDA premarket approval P000018/S005 · decided 2001-06-15
Approval details
- PMA number
- P000018
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE 40 MM BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2000-12-28
- Decision date
- 2001-06-15
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE NOVOSTE(TM) 40 MM BETA-CATH SYSTEM. THE NOVOSTE(TM) 40 MM BETA-CATH(TM) 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 (TREATABLE WITH A 20 MM BALLOON) IN A REFERENCE VESSEL DIAMETER RANGING FROM 2.7 TO 4.0 MM.
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