MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
FDA premarket approval P080006/S026 · decided 2011-06-02
Approval details
- PMA number
- P080006
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2011-05-03
- Decision date
- 2011-06-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF AN ADDITIONAL TESTING LABORATORY FOR STERILIZATION.
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