MEDTRONIC ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR
FDA premarket approval P980035/S245 · decided 2011-11-22
Approval details
- PMA number
- P980035
- Supplement
- S245
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2011-10-05
- Decision date
- 2011-11-22
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE HYBRID DESIGN AND PROTECTION INTEGRATED CIRCUITS APPROVED UNDER THE REFERENCED PMA.
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