PMA P030005S067
- Device
- CONTAK RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S067
- Product code
- NKE
- Decision date
- 2011-04-08
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- APPROVAL FOR THE ADDITION OF A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL TR
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S067
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2011-04-08
- Decision code
- APPR
- Date received
- 2010-08-05
- 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 A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.