PMA P020052S005
- Device
- Response Cv Cardioversion Electrophysiology Cathet
- Applicant
- St. Jude Medical
- PMA number
- P020052
- Supplement
- S005
- Decision date
- 2009-09-22
Current openFDA PMA Record
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER & SYSTEM ACCESSORY EQUIPMENT
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S005
- Product code
- MTE
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Decision date
- 2009-09-22
- Decision code
- OK30
- Date received
- 2009-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE STERILIZATION LOAD.