NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S025 · decided 2003-01-06
Approval details
- PMA number
- P000018
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2002-10-15
- Decision date
- 2003-01-06
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.