PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900
FDA premarket approval P960040/S100 · decided 2006-04-24
Approval details
- PMA number
- P960040
- Supplement
- S100
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-01-28
- Decision date
- 2006-04-24
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE RETROACTIVE MANUFACTURE PROCESS MODIFICATION BY INSERTING A COATING OF MEDICAL ADHESIVE AROUND THE FEEDTHRU WIRES OF THE PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900.
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