MEDTRONIC EN-TRUST 30J/35J ICD FAMILY
FDA premarket approval P980016/S067 · decided 2006-03-02
Approval details
- PMA number
- P980016
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC EN-TRUST 30J/35J ICD FAMILY
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-01-23
- Decision date
- 2006-03-02
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE ICR (INTERCONNECT RIBBON) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS FOR THE MEDTRONIC ENTRUST 30J/35J ICD FAMILY (D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC). SPECIFICALLY, THE INTERCONNECT RIBBON (ICR) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS IS BEING MODIFIED TO PROVIDE A LAP-WELD JOINT AND THE BONDING OF THE SAME MATERIALS.
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