VENTAK PRIZM MODELS 1850 AND 1851
FDA premarket approval P960040/S038 · decided 2003-12-24
Approval details
- PMA number
- P960040
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK PRIZM MODELS 1850 AND 1851
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-11-26
- Decision date
- 2003-12-24
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.
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