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, SELUTE PICOTIP
• Classification Name: permanent pacemaker electrode
• Generic Name: alternate endocardial lead stabilizer component
• Regulation Number: 870.3680
• Applicant: GUIDANT CORP.
• PMA Number: P950001
• Supplement Number: S013
• Date Received: 12/03/2004
• Decision Date: 12/22/2004
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Use of a new biological indicator for the sterilization process.