VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS
FDA premarket approval P960040/S115 · decided 2006-04-05
Approval details
- PMA number
- P960040
- Supplement
- S115
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-03-06
- Decision date
- 2006-04-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR UPDATES TO THE SPECIFICATIONS OF THE DEVICES REGARDING CONFIRMATION OF MEETING HERMETIC AND ARC SUPPRESSION UNDER HIGH VOLTAGE REQUIREMENTS RELATED TO THE ATMOSPHERIC GAS WITHIN THE DEVICE.
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