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: ACUITY STEERABLE FAMILY OF LEADS
• Classification Name: permanent defibrillator electrodes
• Applicant: GUIDANT CORP.
• PMA Number: P050046
• Supplement Number: S003
• Date Received: 08/01/2008
• Decision Date: 08/29/2008
• Product Code: NVY [ Registered Establishments with NVY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in a material supplier.