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 | NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S033 |
Date Received | 05/07/2001 |
Decision Date | 06/07/2001 |
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 FOR LABELING CHANGES. THE CHANGES ARE INTENDED TO: 1) ADD A WARNING THAT RECOMMENDS THAT PHYSICIANS USE CARE WHEN TREATING PATIENTS WITH PRE-EXISTING OBSTRUCTIVE SLEEP APNEA (OSA), AND 2) ADD AND STRENGTHEN PRECAUTIONS REGARDING: A) ELECTROSURGERY, B) THERAPEUTIC ULTRASOUND, C) EXPOSURE TO ENVIRONMENTS THAT ARE PROTECTED BY A WARNING NOTICE PREVENTING ENTRY BY PATIENTS WITH AN IMPLANTED PACEMAKER, AND D) APPLICATION OF OTHER THERAPIES INVOLVING ELECTRIC CURRENT, SUCH AS TENS DEVICES. |
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