PMA P880006S071
- Device
- Sensolog/dialog/regency Family Of Pacemakers
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S071
- Decision date
- 2011-08-03
Current openFDA PMA Record
- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S071
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-08-03
- Decision code
- APPR
- Date received
- 2011-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.