|
Device | CHILLI COOLED ABLATION SYSTEMS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 2710 ORCHARD PKWY. SAN JOSE, CA 95113 |
PMA Number | P990054 |
Supplement Number | S007 |
Date Received | 12/08/2003 |
Decision Date | 01/07/2004 |
Withdrawal Date
|
07/28/2006 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE MANUFACTURING PROCESS WHICH INVOLVED THE USE OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) WITH A SHORTER LABELED INCUBATION TIME OF FOUR (4) HOURS FOR USE IN MONITORING THE EO STERILIZATION CYCLES AND STERILIZATION PROCESS VALIDATION. |