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 | DuraSeal Exact Spine Sealant System |
| Generic Name | Sealant, Dural |
| Applicant | INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-07 |
| Decision Date | 2022-10-07 |
| PMA | P080013 |
| Supplement | S024 |
| Product Code | NQR |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change In The Raw Material Supplier Of The Laminated Film Component Of The Tyvek Pouch Used In Packaging The DuraSeal Products |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080013 | Original Filing | |
| S024 | 2022-09-07 | 30-day Notice |
| S023 | 2021-10-18 | 30-day Notice |
| S022 | ||
| S021 | 2020-08-17 | 30-day Notice |
| S020 | 2020-06-23 | Special (immediate Track) |
| S019 | ||
| S018 | 2019-12-30 | Normal 180 Day Track No User Fee |
| S017 | 2019-06-11 | 30-day Notice |
| S016 | 2018-10-29 | 30-day Notice |
| S015 | 2017-11-30 | Normal 180 Day Track No User Fee |
| S014 | 2017-07-28 | Normal 180 Day Track No User Fee |
| S013 | 2016-04-18 | Real-time Process |
| S012 | ||
| S011 | 2015-02-02 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | 2013-06-04 | 135 Review Track For 30-day Notice |
| S008 | 2013-03-25 | Normal 180 Day Track No User Fee |
| S007 | 2011-07-20 | Special (immediate Track) |
| S006 | 2011-03-21 | Normal 180 Day Track No User Fee |
| S005 | ||
| S004 | 2011-03-02 | Normal 180 Day Track No User Fee |
| S003 | 2010-01-20 | Normal 180 Day Track |
| S002 | 2009-10-14 | Real-time Process |
| S001 | 2009-10-06 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 30381780000048 | P080013 | 009 |
| 30381780000031 | P080013 | 009 |