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 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A |
Generic Name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 DURHAM, NC 27703 |
PMA Number | P900009 |
Supplement Number | S002 |
Date Received | 12/15/1995 |
Decision Date | 04/02/1996 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING FACILITY WHICH IS OWNED AND OPERATED BY HI-TRONICS DESIGNS, INC. AND LOCATED AT 999 WILLOW GROVE ST., BUILDING 2, SUITES 4A, 4B AND 18E, HACKETTSTOWN, NJ 07840. THE SAFHS MODEL 2A WILL BE MANUFACTURED AT THIS SITE |
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