|
Device | CHILLI COOLED ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 2710 ORCHARD PKWY. SAN JOSE, CA 95113 |
PMA Number | P990054 |
Supplement Number | S001 |
Date Received | 01/05/2001 |
Decision Date | 02/15/2001 |
Withdrawal Date
|
07/28/2006 |
Product Code |
LPB |
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 AN ACCELERATED AGING PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE OF THE APPROVED DEVICES. |