DEMA, DIVA AND AFM PULSE GENERATORS
FDA premarket approval P990001/S006 · decided 2001-03-07
Approval details
- PMA number
- P990001
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEMA, DIVA AND AFM PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2001-02-01
- Decision date
- 2001-03-07
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SOFTWARE VERSION PRO VIT VSA02 V6.1 DEMA, DIVA, AND SELECTION OF AFM PULSE GENERATORS.
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