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: GLUTARALDEHYDE SOLUTION SYSTEM
• Classification Name: replacement heart-valve
• Regulation Number: 870.3925
• Applicant: EDWARDS LIFESCIENCES, LLC.
• PMA Number: P860057
• Supplement Number: S076
• Date Received: 02/10/2011
• Decision Date: 03/03/2011
• Product Code: DYE [ Registered Establishments with DYE ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Addition of a new vessel for the gluteraldehyde mixing process.