PMA P980016S420
- Device
- INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S420
- Product code
- LWS
- Decision date
- 2013-06-26
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
Current openFDA PMA Record#
- Device
- INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO II ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD,SECUR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S420
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-06-26
- Decision code
- OK30
- Date received
- 2013-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.