| 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 | MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD |
| Classification Name | permanent pacemaker electrode |
| Generic Name | pacing lead |
| Regulation Number | 870.3680 |
| Applicant | MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT |
| PMA Number | P930039 |
| Supplement Number | S002 |
| Date Received | 06/24/1996 |
| Decision Date | 01/02/1997 |
| Product Code | |
| Advisory Committee |
Cardiovascular |
| Supplement Type | normal 180 day track |
| Supplement Reason | location change: manufacturer |
| Expedited Review Granted? | No |
| Combination Product |
No
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Approval Order Statement Approval for the addition of model 4067, 4568, 5067, 5068 and 5568 to the capsurefix(r) line. These lead models will also be distributed by viatron, inc. , under the tradename "pirout" (models imu49, imu49jb, imx49, imx49b and imu49jb). |
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