This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Cordis® PALMAZ® Balloon-Expandable Stent |
| Generic Name | Stent, Iliac |
| Applicant | Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS023 Date Received09/28/2022 Decision Date12/20/2022 Product Codes NIO NIN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-28 |
| Decision Date | 2022-12-20 |
| PMA | P890017 |
| Supplement | S023 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis US Corporation 14201 N.w. 60th Avenue miami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS023 Date Received09/28/2022 Decision Date12/20/2022 Product Codes NIO NIN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement to Remove References To Obsoleted Accessory Devices And Add Instructions For Unaided Manual Crimping Of The Stent Implant To A Stent Delivery System (i.e., Balloon Catheter) In The Instructions For Use (IFU) Document |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 20705032057292 | P890017 | 015 |
| 20705032057346 | P890017 | 015 |
| 20705032057247 | P890017 | 015 |
| 20705032057223 | P890017 | 015 |
| 20705032057261 | P890017 | 015 |
| 20705032057285 | P890017 | 015 |
| 20705032057315 | P890017 | 015 |