PMA P030005S104
- Device
- INVIVE,INTUA CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S104
- Product code
- NKE
- Decision date
- 2013-11-26
- 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 INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
Current openFDA PMA Record#
- Device
- INVIVE,INTUA CRT-PS
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S104
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-29
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.