PROTECTA DR/VR/XT DR/VR
FDA premarket approval P980016/S294 · decided 2011-05-13
Approval details
- PMA number
- P980016
- Supplement
- S294
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTECTA DR/VR/XT DR/VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-04-15
- Decision date
- 2011-05-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
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