PMA P880006S067
- Device
- SENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S067
- Product code
- NVZ
- Decision date
- 2011-03-04
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record
- Device
- SENSLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S067
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-03-04
- Decision code
- APPR
- Date received
- 2010-06-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 11.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.