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: MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: ptca system
• Regulation Number: 870.5100
• Applicant: MEDI-TECH, INC.
• PMA Number: P840040
• Supplement Number: S001
• Date Received: 01/03/1986
• Decision Date: 03/25/1986
• Product Code: LOX [ Registered Establishments with LOX ]
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No