|
Device | VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830060 |
Supplement Number | S078 |
Date Received | 03/04/2014 |
Decision Date | 03/31/2014 |
Product Code |
LWS |
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 ADD STERILIZATION DETAIL INFORMATION AND TO REMOVE THE CIDEX CLEANING STEP FROM THE INSTRUCTIONS FOR USE. |