ENRHYTHM IPG
FDA premarket approval P980035/S173 · decided 2010-08-02
Approval details
- PMA number
- P980035
- Supplement
- S173
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENRHYTHM IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-06-15
- Decision date
- 2010-08-02
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CHANGE IN DELTA 30H BATTERY SPECIFICATION.
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