PMA P880006S080
- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S080
- Product code
- NIK
- Decision date
- 2012-07-06
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.
Current openFDA PMA Record
- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S080
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-07-06
- Decision code
- APPR
- Date received
- 2012-05-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE MODEL 3330 PROGRAMMER SOFTWARE FROM VERSION 14.1 TO 15.1.