| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD |
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| Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
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| Applicant | ELA MEDICAL, INC. |
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| PMA Number | P060027 |
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| Supplement Number | S008 |
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| Date Received | 11/13/2008 |
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| Decision Date | 02/04/2009 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | real-time process |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the reply pacer embedded software w1. 5. 1 and associated programmer application software version smartview 2. 10 ug1. |
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