| Device Classification Name |
permanent pacemaker electrode
|
| 510(k) Number | K863781 |
| Device Name | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD |
| Applicant |
| INTERMEDICS, INC. |
p.o. box 617 |
freeport,
TX
77541 061 |
|
| Contact | ken bishop |
| Regulation Number | 870.3680 |
| Classification Product Code |
|
| Date Received | 09/26/1986 |
| Decision Date | 11/03/1986 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Cardiovascular
|
| Review Advisory Committee |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
|
|
|