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Device | COOK MBC PTCA BALLOON DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 BLOOMINGTON, IN 47402 |
PMA Number | P990008 |
Date Received | 02/11/1999 |
Decision Date | 09/27/1999 |
Withdrawal Date
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09/28/2009 |
Product Code |
LOX |
Docket Number | 99M-4276 |
Notice Date | 10/18/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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