PMA P030005S110
- Device
- INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S110
- Product code
- NKE
- Decision date
- 2014-05-23
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- INVIVE, INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-PS)
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S110
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2014-05-23
- Decision code
- OK30
- Date received
- 2014-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.