PMA P030005S109
- Device
- INVIVE CRT PS, INTUA CRT PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S109
- Product code
- NKE
- Decision date
- 2014-05-28
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.
Current openFDA PMA Record#
- Device
- INVIVE CRT PS, INTUA CRT PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S109
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2014-05-28
- Decision code
- OK30
- Date received
- 2014-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE AN ALTERNATE INSPECTION METHOD AND EQUIPMENT WITH A CORRESPONDING SPECIFICATION CHANGE.