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 | CORDIS 3.5MM SOFT-WIRE ORION STEERABLE PTCA CATH. |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | CORDIS CORP. P.O. BOX 025700 MIAMI, FL 33102-5700 |
PMA Number | P890032 |
Supplement Number | S016 |
Date Received | 03/25/1992 |
Decision Date | 11/06/1992 |
Withdrawal Date
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09/02/2008 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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