Medtronic Attain Ability Plus Left Ventricular Lead
FDA premarket approval P080006/S139 · decided 2019-08-27
Approval details
- PMA number
- P080006
- Supplement
- S139
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Medtronic Attain Ability Plus Left Ventricular Lead
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2019-07-12
- Decision date
- 2019-08-27
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for labeling updates to the clinical study summary for the post approval study.
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510(k) clearances by this applicant
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|---|---|---|
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