PMA P880086S193
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S193
- Product code
- NVZ
- Decision date
- 2011-07-25
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S193
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-07-25
- Decision code
- APPR
- Date received
- 2010-08-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL OPERTIONS (MY) SDN. BHD. IN BAYAN LEPAS, MALAYSIA.