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 | ELCA CORONARY ATHERECTOMY CATHETERS |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S053 |
Date Received | 01/27/2012 |
Decision Date | 02/24/2012 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement REMOVE REDUNDANT QUALITY CONTROL INSPECTION STEPS IN YOUR FIBER DRAW AND FIBER RE-SPOOLING MANUFACTURING PROCESSES. |
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