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 Dural Sealant System |
| Generic Name | Sealant, Dural |
| Applicant | INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP040034 Supplement NumberS035 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 | P040034 |
| Supplement | S035 |
| 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 NumberP040034 Supplement NumberS035 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 |
|---|---|---|
| P040034 | Original Filing | |
| S035 | 2022-09-07 | 30-day Notice |
| S034 | 2021-10-18 | 30-day Notice |
| S033 | ||
| S032 | 2020-08-17 | 30-day Notice |
| S031 | 2020-05-15 | Real-time Process |
| S030 | 2019-12-30 | Normal 180 Day Track No User Fee |
| S029 | 2019-06-11 | 30-day Notice |
| S028 | 2018-10-29 | 30-day Notice |
| S027 | 2017-11-30 | Normal 180 Day Track No User Fee |
| S026 | 2017-07-21 | 30-day Notice |
| S025 | 2016-04-18 | Real-time Process |
| S024 | 2014-07-08 | Normal 180 Day Track |
| S023 | 2014-02-11 | 30-day Notice |
| S022 | ||
| S021 | 2013-06-04 | 135 Review Track For 30-day Notice |
| S020 | 2011-08-25 | 135 Review Track For 30-day Notice |
| S019 | 2010-12-23 | Special (immediate Track) |
| S018 | ||
| S017 | 2010-08-20 | 30-day Notice |
| S016 | 2010-01-08 | Normal 180 Day Track No User Fee |
| S015 | 2009-10-26 | 30-day Notice |
| S014 | 2009-10-13 | Real-time Process |
| S013 | 2009-08-11 | Real-time Process |
| S012 | 2009-07-29 | 30-day Notice |
| S011 | 2009-06-23 | Normal 180 Day Track No User Fee |
| S010 | ||
| S009 | 2007-05-15 | Real-time Process |
| S008 | 2007-03-01 | 30-day Notice |
| S007 | 2006-08-24 | Real-time Process |
| S006 | 2006-07-28 | Normal 180 Day Track |
| S005 | 2006-06-13 | Normal 180 Day Track No User Fee |
| S004 | 2006-06-08 | Normal 180 Day Track |
| S003 | 2006-05-24 | Normal 180 Day Track No User Fee |
| S002 | 2005-11-17 | Real-time Process |
| S001 | 2005-09-01 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 10381780000020 | P040034 | 024 |
| 10381780000013 | P040034 | 024 |