MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD
FDA premarket approval P010015/S068 · decided 2009-06-05
Approval details
- PMA number
- P010015
- Supplement
- S068
- Supplement type
- Real-Time Process
- Trade name
- MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2009-04-06
- Decision date
- 2009-06-05
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE TO THE DC RESISTANCE SPECIFICATION FOR THE MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE (OTW) LEAD FAMILY.
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