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 | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. SAN DIEGO, CA 92123 |
PMA Number | P910019 |
Supplement Number | S004 |
Date Received | 10/30/1997 |
Decision Date | 12/30/1998 |
Withdrawal Date
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09/06/2007 |
Product Code |
MCX |
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 a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711). |
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