|
Trade Name | Patient Specific Talus Spacer |
Classification Name | prosthesis, total talus replacement, metal |
Generic Name | prosthesis, total talus replacement, metal |
Applicant |
Paragon 28, Inc. |
14445 grasslands dr. |
englewood, CO 80112 |
|
HDE Number | H200001 |
Supplement Number | S007 |
Date Received | 06/28/2024 |
Decision Date | 07/18/2024 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of three (3) potential complications and adverse reactions to the device labeling. |