ENTRUST ICD
FDA premarket approval P980016/S052 · decided 2005-09-30
Approval details
- PMA number
- P980016
- Supplement
- S052
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENTRUST ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-07-26
- Decision date
- 2005-09-30
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO VERIFY ADDITIONAL PROGRAMMING PARAMETERS AT THE POST-STERILIZATION MANUFACTURING STEP. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND ENRHYTHM IMPLANTABLE PULSE GENERATOR RESPECTIVELY.
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