PRIZM, PRIZM 2, VITALITY, VITALITY 2 & VITALITY AVT
FDA premarket approval P960040/S061 · decided 2005-07-21
Approval details
- PMA number
- P960040
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRIZM, PRIZM 2, VITALITY, VITALITY 2 & VITALITY AVT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-06-23
- Decision date
- 2005-07-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- REMOVAL OF A SECOND CYCLE OF ELECTRICAL TESTING FOR CAPACITORS.
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