MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193
FDA premarket approval P010015/S030 · decided 2008-02-14
Approval details
- PMA number
- P010015
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC ATTAIN OTW LV LEAD MODEL 4193
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2007-06-27
- Decision date
- 2008-02-14
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO ADD AN UPDATED VERSION OF THE POST-APPROVAL STUDY SUMMARY FOR THE ATTAIN OTW LV LEAD MODEL 4193 TO THE DEVICE LABELING.
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