| 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 II MODELS 262-16 |
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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 | SULZER INTERMEDICS, INC. |
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| PMA Number | P860007 |
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| Supplement Number | S020 |
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| Date Received | 05/19/1998 |
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| Decision Date | 07/06/1998 |
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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 - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for alternate polyethylene terephthalate glycol (petg) packaging material for the intetach ii, model 262-16 pulse generator. |
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