PMA P020052S006
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S006
- Product code
- MTE
- Decision date
- 2010-06-25
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S006
- Product code
- MTE
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Decision date
- 2010-06-25
- Decision code
- APPR
- Date received
- 2010-05-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.