PMA P880006S066
- Device
- Sensolog/dialog/regency Family Of Pacemakers
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S066
- Decision date
- 2010-06-18
Current openFDA PMA Record
- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S066
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-06-18
- Decision code
- OK30
- Date received
- 2010-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE METHOD OF BIOBURDEN TESTING.