PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
FDA premarket approval P030047/S019 · decided 2011-02-14
Approval details
- PMA number
- P030047
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2010-02-16
- Decision date
- 2011-02-14
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.
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