ATTAIN ABILITTY LV LEAD, 4196, ATTAIN ABILITY PLUS LV LEAD, 4296, ATTAIN ABILITY STRAIGHT LV LEAD, 4296
FDA premarket approval P080006/S046 · decided 2012-11-19
Approval details
- PMA number
- P080006
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATTAIN ABILITTY LV LEAD, 4196, ATTAIN ABILITY PLUS LV LEAD, 4296, ATTAIN ABILITY STRAIGHT LV LEAD, 4296
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2012-10-22
- Decision date
- 2012-11-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS.
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510(k) clearances by this applicant
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