|
Device | BLAZER II CARDIAC ABLATION CATHETER & CABLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S050 |
Date Received | 11/07/2011 |
Decision Date | 12/05/2011 |
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 SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY. |