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. |
|
Device | Infuse Bone Graft |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | Boston Scientific Corp. 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P050053 |
Supplement Number | S040 |
Date Received | 11/13/2017 |
Decision Date | 12/13/2017 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Source manufacturing changes to the absorbable collagen sponge component of Infuse Bone Graft. |
|
|