Note: 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. |
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Device | ABSORBO HP-ABSORBABLE DUSTING POWDER |
Generic Name | Powder, dusting, surgical |
Applicant | INGREDION INCORPORATED 10 FINDERNE AVENUE SUITE C BRIDGEWATER, NJ 08807 |
PMA Number | N80535 |
Supplement Number | S009 |
Date Received | 03/19/1999 |
Decision Date | 07/16/1999 |
Withdrawal Date
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10/03/2013 |
Product Code |
KGP |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
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