MEDTRONIC P1501 DR ENRHYTHM IPG SYSTEM
FDA premarket approval P980035/S053 · decided 2006-02-22
Approval details
- PMA number
- P980035
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC P1501 DR ENRHYTHM IPG SYSTEM
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-01-09
- Decision date
- 2006-02-22
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9987 APPLICATION SOFTWARE VERSION 1.3 AND VERSION 1.5 FOR MEDTRONIC ENRHYTHM IPG AND ENTRUST ICD SYSTEMS.
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