MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS
FDA premarket approval P990001/S031 · decided 2007-06-21
Approval details
- PMA number
- P990001
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-06-11
- Decision date
- 2007-06-21
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGES TO THE XD344 ZENER DIODE.
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