|
Device | EXOGEN 2000+ AND EXOGEN 3000 |
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 | S018 |
Date Received | 01/29/2004 |
Decision Date | 03/12/2004 |
Product Code |
LPQ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TWO DESIGN AND COMPONENT CHANGES: 1) CHANGES TO EXOGEN 2000+ PRINTED CIRCUIT BOARD TO IMPLEMENT CORRECTIVE ACTION FOR FIELD FAILURE AND RETURNS. THIS CORRECTIVE ACTION INVOLVES TWO DESIGN CHANGES: I) REPLACE 2 DIODES ON TE PRINTED CIRCUIT BOARD WITH LIGHT EMITTING DIODES. II) ADD A 1000 PF CAPACITOR TO REDUCE ELECTRICAL NOISE. 2) REPLACE BOTH EXOGEN 2000+ AND EXOGEN 3000 TRANSDUCER CABLES WITH A MORE COST EFFECTIVE MODEL. |