EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI
FDA premarket approval P980016/S516 · decided 2015-02-09
Approval details
- PMA number
- P980016
- Supplement
- S516
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S DR ICD; VR ICD, EVERTA XT DR ICD; EVERA XT VR ICD, MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD , SECURA ICD; VI
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-12
- Decision date
- 2015-02-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF AN ADDITIONAL WELD STRENGTH PROOF TEST.
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