|
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 | S013 |
Date Received | 09/01/2009 |
Decision Date | 01/14/2010 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION. |