Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: SLS II LASER SHEATH
• Classification Name: device, removal, pacemaker electrode, percutaneous
• Applicant: SPECTRANETICS CORP.
• PMA Number: P960042
• Supplement Number: S025
• Date Received: 01/10/2011
• Decision Date: 02/09/2011
• Product Code: MFA [ Registered Establishments with MFA ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to the fusing process for the outer jacket tubing.