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 | LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S090 |
Date Received | 07/22/2008 |
Decision Date | 11/17/2008 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS. |
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