SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH
FDA premarket approval P960042/S042 · decided 2012-10-31
Approval details
- PMA number
- P960042
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2012-10-01
- Decision date
- 2012-10-31
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR MODIFYING THE SLS II AND GLIDELIGHT INSTRUCTION FOR USE MANUALS TO INCLUDE A WARNING AND PRECAUTION STATEMENT AND STRENGTHEN A WARNING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.