PMA P030005S101
- Device
- INTUA
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S101
- Product code
- NKE
- Decision date
- 2013-08-22
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE ETHYLENE OXIDE REMOVAL PHASE.
Current openFDA PMA Record#
- Device
- INTUA
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S101
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2013-08-22
- Decision code
- OK30
- Date received
- 2013-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE ETHYLENE OXIDE REMOVAL PHASE.