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: ACS RX COMET CORONARY DILATION CATHETER
• Classification Name: catheters, transluminal coronary angioplasty, percutaneous
• Generic Name: coronary balloon dilatation catheter
• Regulation Number: 870.5100
• Applicant: GUIDANT CORP.
• PMA Number: P810046
• Supplement Number: S171
• Date Received: 12/23/1996
• Decision Date: 05/12/1997
• Product Code: LOX [ Registered Establishments with LOX ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the acs rx comet(tm) coronary dilatation catheter with the 40 mm balloon lengths with the half sizes (i. E. , 2. 0 mm, 2. 5 mm, 3. 0 mm, 3. 5 mm, 4. 0 mm), the 15 mm balloon lengths with the quarter sizes (i. E. , 2. 75 mm, 3. 25 mm and 3. 75 mm diameters), the 30 mm balloon lengths (i. E. , 2. 75 mm, 3. 25 mm, 3. 75 mm and 4. 0 mm diameters) and a single 20 mm balloon length (i. E. , 1. 5 mm) and modification of the balloon compliance chart of the acs rx comet(tm) coronary dilatation catheter to inlcude data up to 18 atm for balloons with a rated burst pressure (rbp) of 14 atm to be consistent with other ptca manufacturers.