NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S048 · decided 2017-07-13
Approval details
- PMA number
- P000018
- Supplement
- S048
- 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
- 2016-08-19
- Decision date
- 2017-07-13
- Days to decision
- 328 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- Approval for a reduction in the existing minimum dose rate of the Jacketed Radiation Source Trains (JRST) of the Beta-Cath 3.5Fr System from 78.2mGy/s to 64.4mGy/s.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.