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 | VNS THERAPY PULSE GENERATORS |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S081 |
Date Received | 04/30/2007 |
Decision Date | 05/14/2007 |
Product Code |
LYJ |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO ADD ADDITIONAL PRECAUTIONARY INFORMATION TO THE MODEL 300 LEAD PHYSICIAN?S MANUAL AS AN ERRATA SHEET AND TO REVISE THE MODEL 102, 102R, 302 AND 303 VNS THERAPY PHYSICIAN?S MANUAL MODULE ENTITLED ?INTRODUCTION TO THE VNS THERAPY (SYSTEM INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS).? |
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