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 | FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | ABBOTT VASCULAR 26531 YNEZ ROAD BUILDING G MAILING P.O. 9018 TEMECULA, CA 92590 |
PMA Number | P890043 |
Supplement Number | S038 |
Date Received | 12/21/2004 |
Decision Date | 01/14/2005 |
Withdrawal Date
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09/05/2014 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE). |
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