|
Device | CHILLI COOLED RPM CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 2710 ORCHARD PKWY. SAN JOSE, CA 95113 |
PMA Number | P990054 |
Supplement Number | S008 |
Date Received | 05/16/2006 |
Decision Date | 06/13/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF AN ALTERNATE BIOLOGICAL INDICATOR (BI) SUPPLIER. |