VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS
FDA premarket approval P960040/S086 · decided 2005-11-10
Approval details
- PMA number
- P960040
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITALITY FAMILY OF AICDS AND PRIZM 1 FAMILY OF AICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-09-26
- Decision date
- 2005-11-10
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
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