VITATRON IPGS
FDA premarket approval P990001/S030 · decided 2007-04-25
Approval details
- PMA number
- P990001
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON IPGS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-03-27
- Decision date
- 2007-04-25
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE L289-010A/B INTEGRATED CIRCUIT CONTROLLER FOR THE VITATRON C- AND T- PACEMAKER MODELS C60A3, C20A3, T60A1, AND T20A1.
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