CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER(CRT-P) DEVICES
FDA premarket approval P030005/S027 · decided 2005-12-20
Approval details
- PMA number
- P030005
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER(CRT-P) DEVICES
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Guidant Corp.
- Date received
- 2005-12-05
- Decision date
- 2005-12-20
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE HEART FAILURE PARTNER MODEL 2936 MAINTENANCE RELEASE SOFTWARE (SW) VERSION 1.5.
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