ENRHYTHM P1501 DR
FDA premarket approval P980035/S081 · decided 2007-12-04
Approval details
- PMA number
- P980035
- Supplement
- S081
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENRHYTHM P1501 DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2007-11-16
- Decision date
- 2007-12-04
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES THAT ADD TWO ALTERNATE TANTALUM CAPACITORS (XTC017, XTC018) WITH INCREASED VOLTAGE RATINGS TO APPROVED DEVICE COMPONENTS. THE DESIGN MODIFICATIONS ARE INTENDED TO REDUCE MANUFACTURING YIELD LOSS AND ASSOCIATED REWORK.
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