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 | SLS SPECTRANETICS LASER SHEATHS |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S032 |
Date Received | 11/30/2011 |
Decision Date | 02/17/2012 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION. |
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