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 | Straumann® Emdogain® |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY60 Minuteman Roadandover, MA 01810 PMA NumberP930021 Supplement NumberS029 Date Received10/17/2022 Decision Date11/16/2022 Product Code NQA Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-17 |
| Decision Date | 2022-11-16 |
| PMA | P930021 |
| Supplement | S029 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THE STRAUMANN COMPANY 60 Minuteman Road andover, MA 01810 PMA NumberP930021 Supplement NumberS029 Date Received10/17/2022 Decision Date11/16/2022 Product Code NQA Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement - Improved Settings For HPLC Identification (ID) Method For Emdogain (test Method For In-process Control And Final Release Testing)- Removal Of Redundant Acetic Acid Content Determination (release Testing)- Removal Of One Redundant Calcium Concentration Determination (in-process Control)- Removal Of Redundant Sampling Step On Emdogain Gel Bulk(in-process Control |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930021 | Original Filing | |
| S030 | 2023-01-04 | 30-day Notice |
| S029 | 2022-10-17 | 30-day Notice |
| S028 | ||
| S027 | 2021-01-29 | 30-day Notice |
| S026 | 2020-08-12 | 30-day Notice |
| S025 | 2019-08-09 | 30-day Notice |
| S024 | ||
| S023 | 2018-11-02 | 135 Review Track For 30-day Notice |
| S022 | 2018-10-24 | 135 Review Track For 30-day Notice |
| S021 | 2018-10-22 | 135 Review Track For 30-day Notice |
| S020 | 2018-05-10 | 30-day Notice |
| S019 | 2018-04-13 | 135 Review Track For 30-day Notice |
| S018 | 2017-12-15 | 135 Review Track For 30-day Notice |
| S017 | 2016-09-09 | 135 Review Track For 30-day Notice |
| S016 | 2016-04-06 | Normal 180 Day Track |
| S015 | 2015-06-29 | 30-day Notice |
| S014 | 2015-03-02 | Normal 180 Day Track |
| S013 | 2012-09-19 | Normal 180 Day Track No User Fee |
| S012 | 2009-01-12 | Normal 180 Day Track No User Fee |
| S011 | 2008-03-27 | Normal 180 Day Track |
| S010 | 2007-10-09 | Real-time Process |
| S009 | 2006-04-11 | Special (immediate Track) |
| S008 | 2002-09-13 | Normal 180 Day Track |
| S007 | 2002-07-01 | Normal 180 Day Track |
| S006 | 2002-06-17 | Normal 180 Day Track |
| S005 | 2000-07-26 | Normal 180 Day Track |
| S004 | 2000-03-09 | Real-time Process |
| S003 | 1999-05-20 | Normal 180 Day Track |
| S002 | 1999-01-26 | Normal 180 Day Track |
| S001 | 1998-01-05 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 07630031700100 | P930021 | 013 |
| 07630031700025 | P930021 | 013 |
| 07630031700087 | P930021 | 013 |
| 07630031730046 | P930021 | 020 |
| 07630031729989 | P930021 | 020 |
| 07630031730015 | P930021 | 020 |
| 07630031730022 | P930021 | 020 |
| 07630031730039 | P930021 | 020 |
| 07630031747389 | P930021 | 024 |
| 07630031747372 | P930021 | 024 |