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 | Harmony™ Delivery Catheter System |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-31 |
| Decision Date | 2022-11-01 |
| PMA | P200046 |
| Supplement | S012 |
| Product Code | NPV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 3576 Unocal Place building A santa Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Automation Of A Verification Step Undertaken By Sterile Release Personnel (SRP) For Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing (BET) Prior To Final Release Of Product |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200046 | Original Filing | |
| S013 | 2022-11-29 | 30-day Notice |
| S012 | 2022-10-31 | 30-day Notice |
| S011 | 2022-07-26 | 30-day Notice |
| S010 | ||
| S009 | 2022-05-16 | 30-day Notice |
| S008 | 2022-03-11 | Normal 180 Day Track No User Fee |
| S007 | 2022-02-28 | 30-day Notice |
| S006 | 2021-12-02 | 30-day Notice |
| S005 | 2021-07-09 | 30-day Notice |
| S004 | 2021-07-01 | 30-day Notice |
| S003 | ||
| S002 | 2021-04-23 | Special (immediate Track) |
| S001 | 2021-04-05 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00763000341367 | P200046 | 000 |
| 00763000338992 | P200046 | 000 |
| 00763000338985 | P200046 | 000 |