PMA P880086S077
- Device
- AV PLUS DX
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S077
- Product code
- DXY
- Decision date
- 2000-09-07
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
Current openFDA PMA Record#
- Device
- AV PLUS DX
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S077
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2000-09-07
- Decision code
- APPR
- Date received
- 2000-08-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.