PMA P020052S007
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S007
- Product code
- MTE
- Decision date
- 2010-11-05
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Approval order statement
- CHANGES TO THE WIRE-TO-RING AND ANCHOR WIRE BRAZING PROCESS.
Current openFDA PMA Record#
- Device
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY
- Applicant
- St Jude Medical
- PMA number
- P020052
- Supplement
- S007
- Product code
- MTE
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Decision date
- 2010-11-05
- Decision code
- OK30
- Date received
- 2010-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE WIRE-TO-RING AND ANCHOR WIRE BRAZING PROCESS.