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 NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-06-16 |
| PMA | P210006 |
| Supplement | S002 |
| Product Code | QSK |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Vascutek Ltd. newmains Avenue inchinnan PA4 9 PMA NumberP210006 Supplement NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement implementation Of A New In-process Inspection Step, New Equipment For Aeration And New Colorant Resin For A Component Of The Delivery System Of The Thoraflex Hybrid Device |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210006 | Original Filing | |
| S003 | 2022-07-01 | Real-time Process |
| S002 | 2022-05-19 | 30-day Notice |
| S001 |