PMA P850051S054
- Device
- Prevail Pacemakers
- Applicant
- MEDTRONIC Inc.
- PMA number
- P850051
- Supplement
- S054
- Decision date
- 1997-11-18
Current openFDA PMA Record
- Device
- PREVAIL PACEMAKERS
- Applicant
- Medtronic, Inc.
- PMA number
- P850051
- Supplement
- S054
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 1997-11-18
- Decision code
- APPR
- Date received
- 1997-06-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for cell phone labeling for the Prevail, Preva, Prodigy, Thera-i, and Vitatron pacemakers.