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 /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S077 |
Date Received | 03/12/2015 |
Decision Date | 03/24/2015 |
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 NEW TRACEABILITY AND TRACKING SYSTEM AT THE HEREDIA, COSTA RICA LOCATION. |
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