|
Device | SWEET TIP RX MODELS 4143/4144/4145/4243/4244/4245 ACTIVE-FIXATION, STEROID ELUTING, ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960006 |
Supplement Number | S002 |
Date Received | 10/29/1998 |
Decision Date | 11/17/1998 |
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 a change in the IS-1 terminal connector. |