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 | Thoraflex™ Hybrid |
| Generic Name | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment |
| Applicant | Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-09-29 |
| PMA | P210006 |
| Supplement | S003 |
| Product Code | QSK |
| 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 | Vascutek Ltd. newmains Avenue inchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK 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 approval For An Increase In The Labeled Shelf Life For The Thoraflex Hybrid Device From 2 Years To 55 Months. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210006 | Original Filing | |
| S003 | 2022-07-01 | Real-time Process |
| S002 | 2022-05-19 | 30-day Notice |
| S001 |