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.
| Device | PALMAZ BALLOON EXPANDABLE STENTS |
| Classification Name | Stent, Renal |
| Generic Name | Stent, Renal |
| Applicant | CORDIS CORP. |
| Date Received | 1999-07-16 |
| Decision Date | 2000-01-28 |
| PMA | P890017 |
| Supplement | S007 |
| Product Code | NIN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P890017 | | Original Filing |
| S023 |
2022-09-28 |
Real-time Process |
| S022 |
2021-12-08 |
Real-time Process |
| S021 | | |
| S020 |
2019-07-23 |
30-day Notice |
| S019 |
2016-11-01 |
30-day Notice |
| S018 |
2016-03-01 |
135 Review Track For 30-day Notice |
| S017 |
2015-06-24 |
135 Review Track For 30-day Notice |
| S016 |
2015-03-17 |
30-day Notice |
| S015 |
2009-10-01 |
30-day Notice |
| S014 |
2006-01-20 |
Real-time Process |
| S013 | | |
| S012 | | |
| S011 |
2003-04-15 |
Normal 180 Day Track |
| S010 |
2001-12-06 |
Panel Track |
| S009 |
2000-05-26 |
Special (immediate Track) |
| S008 |
2000-03-23 |
Normal 180 Day Track |
| S007 |
1999-07-16 |
Normal 180 Day Track |
| S006 |
1998-12-31 |
Normal 180 Day Track |
| S005 |
1998-09-02 |
30-day Notice |
| S004 |
1994-02-22 |
Normal 180 Day Track |
| S003 | | |
| S002 |
1992-04-06 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices