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 RADIOTHERAPY SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | GUIDANT CORP. 26531 YNEZ RD. TEMECULA, CA 92591-4630 |
PMA Number | P000052 |
Supplement Number | S016 |
Date Received | 01/17/2003 |
Decision Date | 06/27/2003 |
Withdrawal Date
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01/31/2008 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SOURCE BLANK SUBASSEMBLY. THE FACILITY IS LOCATED AT GUIDANT CORPORATION, HOUSTON, TEXAS. |
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