|
Device | THINLINE/FINELINE ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S011 |
Date Received | 01/11/2000 |
Decision Date | 02/23/2000 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to market all previously marketed Intermidics shylets kits under new Guidant modelnumbers and provide an alternate stylet kit package insert. |