PMA P030005S207
- Device
- Contak Renewal TR, Valitude, Invive, and Intua
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S207
- Product code
- NKE
- Decision date
- 2021-04-02
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.
Current openFDA PMA Record#
- Device
- Contak Renewal TR, Valitude, Invive, and Intua
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S207
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the Global Labeling System version 3.0 at select locations.