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: PALMAZ BALLOON-EXPANDABLE STENT
• Classification Name: stent, coronary
• Generic Name: iliac stent
• Applicant: CORDIS CORP., A JOHNSON & JOHNSON CO.
• PMA Number: P890017
• Supplement Number: S015
• Date Received: 10/01/2009
• Decision Date: 10/30/2009
• Product Code: MAF [ Registered Establishments with MAF ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Discontinuance of a redundant inspection.