PMA P020052
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER WITH LUMEN
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S009
- Product code
- MTE
- Decision date
- 2011-12-20
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Approval order statement
- USER OF AN ADDITIONAL STERILIZATION CHAMBER.
Current openFDA PMA Record
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER WITH LUMEN
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S009
- Product code
- MTE
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Decision date
- 2011-12-20
- Decision code
- OK30
- Date received
- 2011-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USER OF AN ADDITIONAL STERILIZATION CHAMBER.