Approval for a change to the packaging materials for the palmaz balloon-expandable stent.
| Device | PALMAZ BALLOON EXPANDABLE STENT |
| Classification Name | Stent, Renal |
| Generic Name | Stent, Renal |
| Applicant | CORDIS CORP. |
| Date Received | 2016-03-01 |
| Decision Date | 2016-09-28 |
| PMA | P890017 |
| Supplement | S018 |
| Product Code | NIN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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