Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific Corp; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P010012
• Supplement Number: S139
• Date Received: 09/11/2006
• Decision Date: 03/06/2007
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR ADDING POST APPROVAL STUDY (PAS) DATA TO THE EASYTRAK IS-1 AND EASYTRAK LV-1 PHYSICIAN MANUALS.