PRIZM/VITALITY
FDA premarket approval P960040/S110 · decided 2006-07-28
Approval details
- PMA number
- P960040
- Supplement
- S110
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- PRIZM/VITALITY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-03-03
- Decision date
- 2006-07-28
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR UPDATING THE GOLD BUMPS INCOMING INSPECTION.
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