VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P960040/S055 · decided 2005-06-14
Approval details
- PMA number
- P960040
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Trade name
- VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-05-26
- Decision date
- 2005-06-14
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- USE OF AN ALTERNATE EPOXY IN THE MANUFACTURE OF POWER MODULES FOR THE VITALITY FAMILY OF ICDS AND THE CONTAK RENEWAL FAMILY OF CRT-D DEVICES.
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