APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
FDA premarket approval P880086/S045 · decided 1998-09-04
Approval details
- PMA number
- P880086
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-03-13
- Decision date
- 1998-09-04
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, jarfalla, Sweden.
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