ADVISA DR IPG
FDA premarket approval P980035/S264 · decided 2012-06-04
Approval details
- PMA number
- P980035
- Supplement
- S264
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVISA DR IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2012-03-07
- Decision date
- 2012-06-04
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADVISA DR IPG MODEL A4DR01 AND APPLICATION SOFTWARE MODEL 9995 VERSION 7.4 FOR CARELINK PROGRAMMER MODEL 2090.
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510(k) clearances by this applicant
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