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 | LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S022 |
Date Received | 08/17/2006 |
Decision Date | 10/10/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS, MODELS 1281, 1282, 1283, 1291, 1292 AND 1293. THE LOCATOR PLUS STYLETS ARE SIMILAR TO THE APPROVED LOCATOR MODEL 4036 STEERABLE STYLET (PMA P960013/S010), BUT WITH SIX DIFFERENT COMBINATIONS OF TIP RADII AND STRAIGHT TIP LENGTHS. THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS ARE INTENDED FOR USE WHEN IMPLANTING COMPATIBLE ST. JUDE MEDICAL ACTIVE FIXATION STRAIGHT ENDOCARDIAL PACEMAKER LEADS, TENDRIL MODEL 1688 SDX AND HIGHER. |
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