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 | BLAZERII TEMPERATURE ABLATION CATHETER, BLAZERII XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATION |
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 | S040 |
Date Received | 03/21/2013 |
Decision Date | 04/18/2013 |
Product Code |
OAD |
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 INTRODUCE AND ALLOW THE USE OF A NEW TEST FIXTURE FOR THE OUT-OF-PLANE INSPECTION. |
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