PMA P830045S072
- Device
- INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S072
- Product code
- KRG
- Decision date
- 2000-10-02
- Generic name
- Programmer, pacemaker
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
Current openFDA PMA Record#
- Device
- INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S072
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 2000-10-02
- Decision code
- APPR
- Date received
- 2000-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.