PMA P030005S085
- Device
- INVIVE CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S085
- Product code
- NKE
- Decision date
- 2012-11-14
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.
Current openFDA PMA Record#
- Device
- INVIVE CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKER
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S085
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2012-11-14
- Decision code
- APPR
- Date received
- 2012-07-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN AUTOMATED VISION SYSTEM DURING SEAL PLUG INSPECTION.