BETA-CATH (TM) SYSTEM
FDA premarket approval P000018 · decided 2000-11-03
Approval details
- PMA number
- P000018
- Trade name
- BETA-CATH (TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2000-04-17
- Decision date
- 2000-11-03
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE BETA-CATH(TM) SYSTEM. THE DEVICE IS INDICATED 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 MM TO 4.0 MM.
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