CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
FDA premarket approval P960040/S062 · decided 2005-07-22
Approval details
- PMA number
- P960040
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-06-24
- Decision date
- 2005-07-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATE SUPPLIER OF THE TRIM RESISTOR ARRAYS USED IN THE HYBRID BUILDS OF THE PULSAR MAX, VENTAK AND CONTAK CD FAMILIES OF DEVICES.
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