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 | Artegraft Collagen Vascular Graft |
| Generic Name | Tissue Graft Of 6mm And Greater |
| Applicant | LeMaitre Vascular, Inc.63 Second Avenueburlington, MA 01803 PMA NumberN16837 Supplement NumberS029 Date Received12/30/2022 Decision Date01/25/2023 Product Code LXA Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-30 |
| Decision Date | 2023-01-25 |
| PMA | N16837 |
| Supplement | S029 |
| Product Code | LXA |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LeMaitre Vascular, Inc. 63 Second Avenue burlington, MA 01803 PMA NumberN16837 Supplement NumberS029 Date Received12/30/2022 Decision Date01/25/2023 Product Code LXA Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add Alternative Facilities For Routine Sterility Testing And Bioburden Testing Of The Artegraft Collagen Vascular Graft Product Line |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N16837 | Original Filing | |
| S029 | 2022-12-30 | 30-day Notice |
| S028 | 2022-09-16 | 30-day Notice |
| S027 | ||
| S026 | 2020-04-07 | 30-day Notice |
| S025 | 2018-06-15 | 30-day Notice |
| S024 | 2017-12-29 | 30-day Notice |
| S023 | 2017-12-19 | 30-day Notice |
| S022 | 2017-08-16 | 30-day Notice |
| S021 | 2015-09-11 | Real-time Process |
| S020 | 2015-04-01 | Special (immediate Track) |
| S019 | 2015-03-06 | Real-time Process |
| S018 | 2014-09-04 | 30-day Notice |
| S017 | 2014-07-30 | 30-day Notice |
| S016 | ||
| S015 | 2014-07-07 | Special (immediate Track) |
| S014 | 2014-06-11 | Real-time Process |
| S013 | ||
| S012 | 2014-02-27 | 30-day Notice |
| S011 | 2013-04-26 | Normal 180 Day Track No User Fee |
| S010 | 2012-09-24 | 135 Review Track For 30-day Notice |
| S009 | 2011-12-28 | 135 Review Track For 30-day Notice |
| S008 | 2011-09-20 | 135 Review Track For 30-day Notice |
| S007 | 2009-06-22 | 30-day Notice |
| S006 | 2008-08-11 | 135 Review Track For 30-day Notice |
| S005 | 2006-11-03 | Real-time Process |
| S004 | 2006-02-01 | 30-day Notice |
| S003 | 1999-07-29 | Normal 180 Day Track |
| S002 | ||
| S001 | 1979-06-29 |
| Device ID | PMA | Supp |
|---|---|---|
| 00316837000367 | N16837 | 000 |
| 00316837000190 | N16837 | 015 |
| 00316837000206 | N16837 | 015 |
| 00316837000213 | N16837 | 015 |
| 00316837000220 | N16837 | 015 |
| 00316837000237 | N16837 | 015 |
| 00316837000244 | N16837 | 015 |
| 00316837000251 | N16837 | 015 |
| 00316837000268 | N16837 | 015 |
| 00316837000275 | N16837 | 015 |
| 00316837000282 | N16837 | 015 |
| 00316837000299 | N16837 | 015 |
| 00316837000305 | N16837 | 015 |
| 00316837000312 | N16837 | 015 |
| 00316837000329 | N16837 | 015 |
| 00316837000336 | N16837 | 015 |
| 00316837000343 | N16837 | 015 |
| 00316837000350 | N16837 | 015 |