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: CYBERTACH
• Classification Name: pulse-generator, single chamber, single
• Generic Name: programable pulse generator
• Applicant: GUIDANT CORP.
• PMA Number: P820022
• Supplement Number: S004
• Date Received: 12/03/2004
• Decision Date: 12/22/2004
• Product Code: LWW
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

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