PMA P980016S246
- Device
- ENTRUST
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S246
- Product code
- LWS
- Decision date
- 2010-07-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADDING NEW TEST EQUIPMENT.
Current openFDA PMA Record#
- Device
- ENTRUST
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S246
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2010-07-08
- Decision code
- OK30
- Date received
- 2010-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDING NEW TEST EQUIPMENT.