SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR
FDA premarket approval P980016/S339 · decided 2012-04-16
Approval details
- PMA number
- P980016
- Supplement
- S339
- Supplement type
- Real-Time Process
- Trade name
- SECURA/MAXIMO II/PROTECTA /PROTECTA XT/ENTRUST/ENTRUST DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-22
- Decision date
- 2012-04-16
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE LIFE TEST SPECIFICATIONS OF HIGH VOLTAGE CAPACITORS.
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