| 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 | INTERTACH |
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| Classification Name | pulse-generator, single chamber, single |
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| Generic Name | single chamber, antitachycardia, pulse generator,pacemaker, implantable |
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| Applicant | BOSTON SCIENTIFIC CORP. |
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| PMA Number | P860007 |
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| Supplement Number | S024 |
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| Date Received | 03/26/2012 |
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| Decision Date | 04/23/2012 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Implementation of a new acceptance methodology at the quality system level. |
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