INTEGRITY AFX DR/INTEGRITY SR
FDA premarket approval P880086/S078 · decided 2000-10-02
Approval details
- PMA number
- P880086
- Supplement
- S078
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTEGRITY AFX DR/INTEGRITY SR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-09-07
- Decision date
- 2000-10-02
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.
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