|
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 | S025 |
Date Received | 05/16/2012 |
Decision Date | 06/27/2012 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE PROPOSED LABELING REVISIONS RELATED TO THE APPEARANCE OF THE RECONSTITUTED PRODUCT AND WARNING STATEMENT ABOUT USE IN PATIENTS SUSPECTED OF HAVING CANCER AT THE PRODUCT APPLICATION SITE. |