PALMAZ BALLOON EXPANDABLE STENTS
FDA premarket approval P890017/S007 · decided 2000-01-28
Approval details
- PMA number
- P890017
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PALMAZ BALLOON EXPANDABLE STENTS
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 1999-07-16
- Decision date
- 2000-01-28
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval is for additional models of the PALMAZ balloon expandable stent and the use of the OPTA LP and Powerflex Plus balloon catheters as delivery systems for the stents. The additional stent models include stents with an expansion range from 6 to 8 mm and lengths from 10 to 30 mm.
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