- Device
- SUSTAIN XL SC, DC, SR, DR PACEMAKER MODELS PM1134, PM2134, PM1136, PM2136
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S210
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-10-14
- Decision code
- APPR
- Date received
- 2011-09-07
- 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 CARDIAC RHYTHM MANAGEMENT DIVISION IN PENANG, MALAYSIA.