PMA P030005S022
- Device
- RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S022
- Product code
- NKE
- Decision date
- 2007-08-06
- 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 AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
Current openFDA PMA Record#
- Device
- RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S022
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2007-08-06
- Decision code
- APPR
- Date received
- 2005-10-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.