VITATRON DIVA PLATFORM
FDA premarket approval P990001/S005 · decided 2001-01-08
Approval details
- PMA number
- P990001
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITATRON DIVA PLATFORM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2000-11-08
- Decision date
- 2001-01-08
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE DATE TO 18 MONTHS FROM 12 MONTHS AND RELATED LABELING CHANGES.
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