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: REACH(TM).14 PTCA CATHETER
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: Abbott Vascular, Inc.; 26531 Ynez Rd.; Temecula, CA 92591
• PMA Number: P850021
• Supplement Number: S016
• Date Received: 10/15/1991
• Decision Date: 01/07/1992
• Withdrawal Date: 06/30/2009
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No