PMA P030005S128
- Device
- VALITUDE CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S128
- Product code
- NKE
- Decision date
- 2015-08-08
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.
Current openFDA PMA Record#
- Device
- VALITUDE CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S128
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2015-08-08
- Decision code
- OK30
- Date received
- 2015-07-17
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD AN AUTOMATED VISION INSPECTION SYSTEM FOR THE COIL SPRING INNER DIAMETER OF THE REFERENCED DEVICES AT THE SUPPLIER, BAL SEAL.