- Device
- META DDDR PACING SYSTEM
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- PMA number
- P900070
- Supplement
- S010
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1996-07-11
- Decision code
- APPR
- Date received
- 1995-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING