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 | E P TECH EPT-1000 CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S007 |
Date Received | 02/11/1997 |
Decision Date | 06/24/1997 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO PERMIT EPT'S MANUFACTURING FACILITY, LOCATED AT 350 POTRERO AVE., SUNNYVALE, CA 94086, TO BE MOVED TO A NEW FACILITY AT 2710 ORCHARD PARKWAY, SAN JOSE, CA. |
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