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: INTERTACH(R) FAMILY OF PULSE GENERATORS
• Classification Name: pulse-generator, single chamber, single
• Generic Name: single chamber, antitachycardia, pulse generator
• Applicant: INTERMEDICS, INC.
• PMA Number: P860007
• Supplement Number: S016
• Date Received: 09/18/1995
• Decision Date: 05/21/1996
• Product Code: LWW
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate sterilization process.