VITALITY
FDA premarket approval P960040/S082 · decided 2005-09-23
Approval details
- PMA number
- P960040
- Supplement
- S082
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITALITY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-24
- Decision date
- 2005-09-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE MANUFACTURING PROCESS ELIMINATING VACCUUM BAKE AND INSPECTION AND THE FIRST SHELF TEST STEP.
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