PMA P980016S104
- Device
- ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S104
- Product code
- LWS
- Decision date
- 2007-08-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGES INCLUDING: 1) MOVING THE ACCELEROMETER TESTING OPERATION EARLIER IN THE MANUFACTURING FLOW; 2) MOVING THE PATIENT ALERT RESTING OPERATION EARLIER IN THE MANUFACTURING PROCESS; AND 3) PERFORMING THE MEDICAL ADHESIVE CURING AND DEVICE PRE-HEAT PROCESS IN A SINGLE OVEN.
Current openFDA PMA Record#
- Device
- ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S104
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-08-10
- Decision code
- OK30
- Date received
- 2007-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES INCLUDING: 1) MOVING THE ACCELEROMETER TESTING OPERATION EARLIER IN THE MANUFACTURING FLOW; 2) MOVING THE PATIENT ALERT RESTING OPERATION EARLIER IN THE MANUFACTURING PROCESS; AND 3) PERFORMING THE MEDICAL ADHESIVE CURING AND DEVICE PRE-HEAT PROCESS IN A SINGLE OVEN.