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 | EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S022 |
Date Received | 01/16/2004 |
Decision Date | 02/12/2004 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
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 MODIFY LEAD MANUALS. |
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