PRIZM/ VITALITY
FDA premarket approval P960040/S088 · decided 2007-08-06
Approval details
- PMA number
- P960040
- Supplement
- S088
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRIZM/ VITALITY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-10-11
- Decision date
- 2007-08-06
- Days to decision
- 664 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
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