|
Device | MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050 |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S020 |
Date Received | 09/27/2007 |
Decision Date | 10/29/2007 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCORPORATION OF A WARNING AND EMC STATEMENT TO THE MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP) OPERATOR?S MANUAL. |