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 | TRIDYNE Vascular Sealant |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC.60 Technology Dr.irvine, CA 92618 PMA NumberP150016 Supplement NumberS022 Date Received08/08/2022 Decision Date09/07/2022 Product Code NBE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-08 |
| Decision Date | 2022-09-07 |
| PMA | P150016 |
| Supplement | S022 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 PMA NumberP150016 Supplement NumberS022 Date Received08/08/2022 Decision Date09/07/2022 Product Code NBE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Relocation Of The Glass Cartridge Syringe Manufacturing Supplier Site |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150016 | Original Filing | |
| S022 | 2022-08-08 | 30-day Notice |
| S021 | 2021-08-16 | 30-day Notice |
| S020 | 2021-01-14 | 30-day Notice |
| S019 | ||
| S018 | 2020-05-01 | 135 Review Track For 30-day Notice |
| S017 | 2019-01-23 | 30-day Notice |
| S016 | 2018-08-17 | 30-day Notice |
| S015 | 2018-06-27 | 30-day Notice |
| S014 | 2018-05-14 | 30-day Notice |
| S013 | 2018-04-06 | 30-day Notice |
| S012 | 2018-01-22 | Real-time Process |
| S011 | 2018-01-09 | 30-day Notice |
| S010 | 2017-11-29 | Normal 180 Day Track No User Fee |
| S009 | 2017-11-28 | 135 Review Track For 30-day Notice |
| S008 | 2017-11-28 | 30-day Notice |
| S007 | 2017-11-28 | 30-day Notice |
| S006 | 2017-10-23 | 30-day Notice |
| S005 | 2017-04-10 | Real-time Process |
| S004 | ||
| S003 | 2016-10-25 | 30-day Notice |
| S002 | 2016-10-19 | 30-day Notice |
| S001 | 2016-06-29 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 10801741099387 | P150016 | 000 |
| 10801741099363 | P150016 | 000 |
| 20801741099377 | P150016 | 000 |