SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L
FDA premarket approval P880086/S010 · decided 1993-01-11
Approval details
- PMA number
- P880086
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1991-03-29
- Decision date
- 1993-01-11
- Days to decision
- 654 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR RELOCATING THE MANUFACTURING FACILITIES TO 15900 VALLEYVIEW COURT, SYLMAR, CALIFORNIA, 91392-9221
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