VITALITY HE
FDA premarket approval P960040/S128 · decided 2006-06-22
Approval details
- PMA number
- P960040
- Supplement
- S128
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITALITY HE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-05-23
- Decision date
- 2006-06-22
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ADD WARNING REGARDING CORRECT DEVICE IMPLANT ORIENTATION.
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