MEDTRONIC ADAPTA,VERSA,&SENSIA IMPLANTABLE PULSE GENERATOR
FDA premarket approval P980035/S043 · decided 2006-07-17
Approval details
- PMA number
- P980035
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ADAPTA,VERSA,&SENSIA IMPLANTABLE PULSE GENERATOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-07-01
- Decision date
- 2006-07-17
- Days to decision
- 381 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADAPTA, VERSA AND SENSIA FAMILIES OF IMPLANTABLE PULSE GENERATORS WITH SOFTWARE SW003 VERSION 1.3.
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510(k) clearances by this applicant
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