Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BLAZER II XP/PRIME XP CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P020025 |
Supplement Number | S028 |
Date Received | 06/09/2011 |
Decision Date | 07/19/2011 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510. |
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