|
Device | CONTAK RENEWAL AND CONTAK RENEWAL 3 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S016 |
Date Received | 10/06/2003 |
Decision Date | 10/24/2003 |
Product Code |
NIK |
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 FOR LABELING CHANGES TO THE SYSTEM GUIDE AND TECHNICAL MANUALS FOR THE CONTAK RENEWAL AND CONTAK RENEWAL 3 SYSTEMS. |