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 | ASPIRESR GENERATOR -MODEL 106 |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S182 |
Date Received | 07/01/2015 |
Decision Date | 12/18/2015 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USING A 2-POSITION PRE-SURGICAL SURFACE ELECTROCARDIOGRAPH (ECG) ASSESSMENT PROCEDURE TO IDENTIFY IMPLANT LOCATION. |
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