PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES
FDA premarket approval P960040/S146 · decided 2007-10-18
Approval details
- PMA number
- P960040
- Supplement
- S146
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-07-23
- Decision date
- 2007-10-18
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MINOR LABELING CHANGES FOR THE PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES.
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