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 | INFUSE BONE GRAFT |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | MEDTRONIC Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P050053 |
Supplement Number | S008 |
Date Received | 02/19/2008 |
Decision Date | 05/13/2008 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO ADDRESS WARNINGS ABOUT IMPROPER PREPARATION OF INFUSE BONE GRAFT AND OVERFILLING OF BONE DEFECTS. |
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