PROTECTA DR/VR/XT DR/VR ICD
FDA premarket approval P980016/S302 · decided 2011-06-10
Approval details
- PMA number
- P980016
- Supplement
- S302
- Supplement type
- 30-Day Notice
- Trade name
- PROTECTA DR/VR/XT DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-13
- Decision date
- 2011-06-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE THE CLEANING AREA OF THE DEVICES.
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