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: LASTAC SYSTEM
• Generic Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Applicant: G V Medical, Inc.; 3750 Annapolis Ln.; Minneapolis, MN 55441
• PMA Number: P870071
• Supplement Number: S005
• Date Received: 03/13/1989
• Decision Date: 03/31/1989
• Product Code: LPC
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No