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: SELUTE
• Classification Name: permanent defibrillator electrodes
• Generic Name: alternate endocardial lead stabilizer component
• Applicant: GUIDANT CORP.
• PMA Number: P950001
• Supplement Number: S017
• Date Received: 04/13/2006
• Decision Date: 05/12/2006
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Changes to the bioburden sampling plan.