PMA P030005S147
- Device
- INVIVE CRT-P Models V172, V173; INTUA CRT-P Models V272, V273; VALITUDE Model U125; VALITUDE X4 Model U128;
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S147
- Product code
- NKE
- Decision date
- 2016-12-12
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.
Current openFDA PMA Record#
- Device
- INVIVE CRT-P Models V172, V173; INTUA CRT-P Models V272, V273; VALITUDE Model U125; VALITUDE X4 Model U128;
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S147
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2016-12-12
- Decision code
- OK30
- Date received
- 2016-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.