PMA P820018S067
- Device
- AUTIMA AURORA CARDIAC PACING SYSTEM
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S067
- Product code
- LWP
- Decision date
- 1996-04-23
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR SUBSTRATE DESIGN CHANGES ALREADY IMPLEMENTED
Current openFDA PMA Record
- Device
- AUTIMA AURORA CARDIAC PACING SYSTEM
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S067
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-04-23
- Decision code
- APPR
- Date received
- 1995-03-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SUBSTRATE DESIGN CHANGES ALREADY IMPLEMENTED