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: RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT
• Classification Name: system,pacing,temporary,acute,internal atrial defibrillation
• Generic Name: cardiac ablation catheter
• Applicant: ST. JUDE MEDICAL
• PMA Number: P020052
• Supplement Number: S008
• Date Received: 09/15/2011
• Decision Date: 10/13/2011
• Product Code: MTE [ Registered Establishments with MTE ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Eliminate the uv post trim process.