PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR
FDA premarket approval P980016/S338 · decided 2012-03-09
Approval details
- PMA number
- P980016
- Supplement
- S338
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-13
- Decision date
- 2012-03-09
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
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