VITALITY 2 SYSTEM GUIDE
FDA premarket approval P960040/S043 · decided 2004-05-04
Approval details
- PMA number
- P960040
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITALITY 2 SYSTEM GUIDE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-04-08
- Decision date
- 2004-05-04
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MINOR UPDATES TO THE VITALITY 2 SYSTEM GUIDE CLINICAL SECTION.
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