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 revised labeling. The request to replace the warning statement: "warning-the powder should be washed off gloves with sterile solution before treated gloves are used in surgery," with the statement: "caution: after donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.
| Device | ABSORBO HP-ABSORBABLE DUSTING POWDER |
| Generic Name | Powder, Dusting, Surgical |
| Applicant | INGREDION INCORPORATED |
| Date Received | 1999-03-19 |
| Decision Date | 1999-07-16 |
| PMA | N80535 |
| Supplement | S009 |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INGREDION INCORPORATED 10 Finderne Avenue suite C bridgewater, NJ 08807 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N80535 | Original Filing | |
| S009 | 1999-03-19 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1990-05-22 | Normal 180 Day Track |
| S005 | 1989-08-21 | Normal 180 Day Track |
| S004 | 1974-09-08 | Normal 180 Day Track |
| S003 | 1973-03-02 | Normal 180 Day Track |
| S002 | 1973-03-02 | Normal 180 Day Track |
| S001 | 1973-03-02 | Normal 180 Day Track |