PMA P980016S294
- Device
- PROTECTA DR/VR/XT DR/VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S294
- Product code
- LWS
- Decision date
- 2011-05-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- PROTECTA DR/VR/XT DR/VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S294
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-05-13
- Decision code
- OK30
- Date received
- 2011-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.