AV PLUS DX
FDA premarket approval P880086/S077 · decided 2000-09-07
Approval details
- PMA number
- P880086
- Supplement
- S077
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AV PLUS DX
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-08-11
- Decision date
- 2000-09-07
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
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