PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S
FDA premarket approval P980016/S353 · decided 2012-06-13
Approval details
- PMA number
- P980016
- Supplement
- S353
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-05-14
- Decision date
- 2012-06-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ALIGN HEADER MANUFACTURING PROCESSES OF THE PROTECTA XT VR (D314VRM), PROTECTA VR (D334VRM), SECURA VR (D204VRM) AND MAXMIO II VR (D264VRM) DF4 ICDS WITH CURRENTLY MANUFACTURED DEVICES.
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