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.
Approval for a manufacturing site located at pacmoore process technologies, llc. In mooresville, indiana.
| Device | PURE-DENT B851 ABSORBABLE DUSTING POWDER |
| Generic Name | Powder, Dusting, Surgical |
| Applicant | GRAIN PROCESSING CORP. |
| Date Received | 2011-02-17 |
| Decision Date | 2011-10-07 |
| PMA | P890070 |
| Supplement | S005 |
| Product Code | KGP |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GRAIN PROCESSING CORP. 1600 Oregon St. muscatine, IA 52761 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890070 | Original Filing | |
| S005 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 1994-08-18 | Special (immediate Track) |
| S002 | 1994-04-25 | Normal 180 Day Track |
| S001 | 1991-02-01 | Normal 180 Day Track |