| 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 | FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads) |
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| Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
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| Applicant | Boston Scientific
4100 Hamline Ave. N
St Paul, MN 55112 |
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| PMA Number | P960004 |
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| Supplement Number | S085 |
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| Date Received | 04/30/2018 |
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| Decision Date | 07/27/2018 |
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| Product Code |
NVN |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity. |
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