|
Device | FINELINE |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S005 |
Date Received | 06/14/1999 |
Decision Date | 07/01/1999 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the ThinLine(TM) pacing leads under the Guidant FINELINE(TM) trade name. These devices are indicated for permanent pacing and sensing in the ventricle and/or the atrium when used with a compatible pulse generator. |