PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRM
FDA premarket approval P010031/S327 · decided 2012-09-04
Approval details
- PMA number
- P010031
- Supplement
- S327
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTECTA CRT-D, D334TRG, D334TRM, PROTECTA XT CRT-D, D314TRG, D314TRM
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-06
- Decision date
- 2012-09-04
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SOFTWARE UPDATE TO A CD SURGE TEST.
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