|
Device | EASYTRAK 2 FAMILY OF LEADS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S152 |
Date Received | 08/15/2007 |
Decision Date | 11/09/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO CHANGE THE MEDICAL ADHESIVE USED FOR THE EASYTRAK 2 FAMILY OF LEADS. |