PMA P980016S344
- Device
- GEM DR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S344
- Product code
- LWS
- Decision date
- 2012-04-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- GEM DR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S344
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-04-02
- Decision code
- OK30
- Date received
- 2012-03-07
- Supplement type
- 30-Day Notice
- Approval order statement
- VARIOUS CHANGES TO THE GROMMET MANUFACTURING PROCESS.