PMA P820018S061
- Device
- AUTIMA/AURORA CARDIAC PACING SYSTEM
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S061
- Product code
- LWP
- Decision date
- 1995-07-12
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR ADDITION OF NON-INVASIVE PROGRAMMED STIMULATION (NIPS)
Current openFDA PMA Record
- Device
- AUTIMA/AURORA CARDIAC PACING SYSTEM
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S061
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1995-07-12
- Decision code
- APPR
- Date received
- 1993-11-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDITION OF NON-INVASIVE PROGRAMMED STIMULATION (NIPS)