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 | HeartLight® X3 Catheter with Excalibur Balloon™ |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | CARDIOFOCUS, INC.500 Nickerson Roadmarlborough, MA 01752 PMA NumberP150026 Supplement NumberS013 Date Received03/04/2022 Decision Date04/02/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-04-02 |
| PMA | P150026 |
| Supplement | S013 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIOFOCUS, INC. 500 Nickerson Road marlborough, MA 01752 PMA NumberP150026 Supplement NumberS013 Date Received03/04/2022 Decision Date04/02/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For A Manufacturing Site Located At Sterigenics, Inc., 84 Park Road, Queensbury, NY 12804 As An Alternate Sterilization Site For The HeartLight X3 Catheter With Excalibur Balloon |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150026 | Original Filing | |
| S013 | 2022-03-04 | Normal 180 Day Track |
| S012 | 2021-01-06 | Normal 180 Day Track |
| S011 | 2020-06-01 | Normal 180 Day Track No User Fee |
| S010 | 2020-01-22 | 30-day Notice |
| S009 | 2019-12-18 | 30-day Notice |
| S008 | ||
| S007 | 2019-08-13 | Real-time Process |
| S006 | 2019-05-29 | Special (immediate Track) |
| S005 | 2019-01-08 | Normal 180 Day Track |
| S004 | 2018-04-04 | 30-day Notice |
| S003 | 2017-11-09 | Real-time Process |
| S002 | 2017-08-09 | Normal 180 Day Track |
| S001 | 2017-05-05 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00868976000178 | P150026 | 000 |
| 00868976000161 | P150026 | 000 |
| 00868976000154 | P150026 | 000 |
| 00868976000130 | P150026 | 000 |
| 00868976000123 | P150026 | 000 |
| 00868976000116 | P150026 | 000 |
| 00868976000109 | P150026 | 000 |