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 | GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | GUIDANT CORP. 26531 YNEZ RD. TEMECULA, CA 92591-4630 |
PMA Number | P000052 |
Supplement Number | S005 |
Date Received | 02/21/2002 |
Decision Date | 08/22/2002 |
Withdrawal Date
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01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR HARDWARE AND SOFTWARE CHANGES FOR THE GALILEO SOURCE DELIVERY UNIT, I.E., AN ALTERNATE PRIMARY CIRCUIT BOARD (AMPRO BOARD), LCD DISPLAY AND ASSOCIATED SOFTWARE. THESE CHANGES ARE APPLICABLE TO THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM, WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, THE 27 MM 32P SOURCE WIRE AND THE 27 MM GALILEO CENTERING CATHETER. |
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