|
Device | THINLINE ENDOCARDIAL PACING LEADS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S001 |
Date Received | 01/27/1997 |
Decision Date | 08/29/1997 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the ThinLine(TM) EZ Model 438-10 Endocardial Pacing Lead. This device is indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator. |