PMA P880006S064
- Device
- SENSOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S064
- Product code
- NVZ
- Decision date
- 2010-03-16
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record
- Device
- SENSOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S064
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-03-16
- Decision code
- APPR
- Date received
- 2009-09-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.