VIGOR DR/SR AND DISCOVERY MERIDIAN AR
FDA premarket approval P940031/S027 · decided 2003-03-21
Approval details
- PMA number
- P940031
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VIGOR DR/SR AND DISCOVERY MERIDIAN AR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2002-12-12
- Decision date
- 2003-03-21
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
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