Premarket Approval (PMA)

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.

• Device: SLS II LASER SHEATH
• Generic Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• Applicant: Spectranetics (Philips); 9965 Federal Dr.; Colorado Springs, CO 80921
• PMA Number: P960042
• Supplement Number: S025
• Date Received: 01/10/2011
• Decision Date: 02/09/2011
• Product Code: MFA
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE TO THE FUSING PROCESS FOR THE OUTER JACKET TUBING.