Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: AIS EXIMER LASER ANGIOPLASTY
• Generic Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Applicant: SPECTRANETICS CORP.; 9965 Federal Drive; Colorado Springs, CO 80921
• PMA Number: P900032
• Date Received: 05/02/1990
• Decision Date: 01/31/1992
• Withdrawal Date: 09/13/2011
• Product Code: LPC
• Docket Number: 92M-0078
• Notice Date: 03/16/1992
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S006 S013 S015 S016 S018 S019 S020